Search Clinical Trials
There are research studies that need you! MetroHealth conducts research studies and clinical trials to find cures and make new discoveries to improve the health and wellness of our community.
If you are interested in taking part in a MetroHealth research study, please review the list below for all active and enrolling clinical trials at MetroHealth OR narrow your search for specific conditions.
Condition of Interest |
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Effectiveness RCT of Customized Adherence Enhancement
Bipolar Disorder
Approximately one in two individuals with bipolar disorder (BD) are non-adherent with
medication, often leading to severe and negative consequences. Unfortunately, there is no
widely used evidence-based approach to target poor adherence among individuals with BD.
Building upon positive efficacy trial... expand
Approximately one in two individuals with bipolar disorder (BD) are non-adherent with medication, often leading to severe and negative consequences. Unfortunately, there is no widely used evidence-based approach to target poor adherence among individuals with BD. Building upon positive efficacy trial results, the proposed project will test the effectiveness of technology-facilitated Customized Adherence Enhancement (CAE) vs. enhanced treatment as usual (eTAU) using a prospective randomized controlled design in public mental health care settings and preferentially enrolling poorly adherent/high-risk individuals with BD. Deliverables include a curriculum-driven adherence enhancement approach that can be implemented in public healthcare settings and which can improve outcomes for the most vulnerable groups of people with BD. Type: Interventional Start Date: Feb 2022 |
Study of V117957 in Interstitial Cystitis/Bladder Pain Syndrome
Interstitial Cystitis/Bladder Pain Syndrome
The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957
in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo. expand
The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with interstitial cystitis/bladder pain syndrome, compared to placebo. Type: Interventional Start Date: May 2022 |
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body...
Juvenile Psoriatic Arthritis
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune
system attacks healthy cells and tissues causing joint pain, stiffness, and swelling.
Symptoms can get worse and go away for periods of time. PsA that begins before a
patient's 16th birthday is called juvenile PsA... expand
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms. Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide. Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Jul 2024 |
Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive...
Extensive Stage Lung Small Cell Carcinoma
This phase II/III trial compares the effect of adding radiation therapy to the usual
maintenance therapy with atezolizumab versus atezolizumab alone in patients who have
already received atezolizumab plus chemotherapy for the treatment of small cell lung
cancer that has spread outside of the lung... expand
This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone. Type: Interventional Start Date: Jan 2021 |
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk...
Ovarian Carcinoma
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy
and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for
individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal
of fallopian tubes, and bilateral salpingo-oophorectomy... expand
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations. Type: Interventional Start Date: Sep 2020 |
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX)...
Locally Advanced Rectal Carcinoma
Stage II Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
This phase II trial compares the effect of irinotecan versus oxaliplatin after
long-course chemoradiation in patients with stage II-III rectal cancer. Combination
chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and
oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin,... expand
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer. Type: Interventional Start Date: Dec 2022 |
Improving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation
Stroke
Rehabilitation
Hand
This pilot study for stroke patients with chronic upper limb hemiplegia will examine the
effects of non-invasive brain stimulation and neuromuscular electrical stimulation on
hand motor control and corticospinal excitability. Specifically, this study will
investigate the effects of timing and delivery... expand
This pilot study for stroke patients with chronic upper limb hemiplegia will examine the effects of non-invasive brain stimulation and neuromuscular electrical stimulation on hand motor control and corticospinal excitability. Specifically, this study will investigate the effects of timing and delivery of tDCS in conjunction with contralaterally controlled functional electrical stimulation. Type: Interventional Start Date: Aug 2019 |
Feasibility of Early Gabapentin as an Intervention for Neurorecovery
Spinal Cord Injuries
The objective of the proposed study is to conduct the first ever prospective,
dose-exploration trial to test the feasibility of early administration of gabapentin as
an intervention for neurorecovery. This research project falls under the Intervention
Development stage of research as the primary goal... expand
The objective of the proposed study is to conduct the first ever prospective, dose-exploration trial to test the feasibility of early administration of gabapentin as an intervention for neurorecovery. This research project falls under the Intervention Development stage of research as the primary goal is to assess the feasibility of conducting a well-designed intervention efficacy study in the future. Type: Interventional Start Date: Mar 2022 |
Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive...
Endometrial Serous Adenocarcinoma
Uterine Corpus Carcinosarcoma
This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk
(Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the
usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with
HER2 positive endometrial serous carcinoma... expand
This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. Type: Interventional Start Date: Nov 2022 |
A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
Short Cervical Length
This protocol outlines a randomized trial of 630 women evaluating the use of micronized
vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth
in women carrying twins and with a cervical length of less than 30 millimeters. expand
This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters. Type: Interventional Start Date: Nov 2015 |
Post Market Clinical Evaluation of Gamma 4
Femoral Fracture
This is a prospective, multi-center, non-randomized, post-market clinical investigation
of the Gamma 4 System. Neither subjects nor investigators are blinded to treatment.
It is anticipated that a total of 100 subjects will be enrolled at five sites. Total
duration of enrollment, 12 month follow-up... expand
This is a prospective, multi-center, non-randomized, post-market clinical investigation of the Gamma 4 System. Neither subjects nor investigators are blinded to treatment. It is anticipated that a total of 100 subjects will be enrolled at five sites. Total duration of enrollment, 12 month follow-up and analysis is expected to take approximately 30 months. The clinical investigation has been designed to follow the surgeon's standard of care for subjects treated with a cephalomedullary nail for femoral fractures or and deformities, in addition to a 12 month follow-up visit. The primary endpoint of this clinical investigation is demonstration of bone consolidation by 12 months. Type: Observational Start Date: Mar 2023 |
Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury
Spinal Cord Injuries
Spinal Cord Injury at C5-C7 Level
Spinal Cord Injury Cervical
Spinal Cord Injury at C5-C7 Level With Complete Lesion
Spinal Cord Injury at C5-C7 Level With Incomplete Lesion
This study is to evaluate the use of a fully implanted device for providing hand
function, reach, and trunk function to individuals with cervical spinal cord injury.
Funding Sources:
FDA OOPD NIH NINDS expand
This study is to evaluate the use of a fully implanted device for providing hand function, reach, and trunk function to individuals with cervical spinal cord injury. Funding Sources: FDA OOPD NIH NINDS Type: Interventional Start Date: Dec 2014 |
Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With...
Systemic Lupus Erythematosus
The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab
compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top
of standard-of-care (SoC) treatment in participants with active systemic lupus
erythematosus (SLE). expand
The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE). Type: Interventional Start Date: Mar 2023 |
MILD® Percutaneous Image-Guided Lumbar Decompression: a Medicare Claims Study
Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary
surgical and minimally invasive intervention post index procedure, as well as harms
associated with the MILD procedure, at 24 months post-treatment with MILD, tested against
a control group of similar patients... expand
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor. Type: Observational Start Date: Mar 2017 |
tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia
Stroke
Upper Extremity Paresis
Hemiplegia
After a stroke, it is very common to lose the ability to open the affected hand.
Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive
brain stimulation may help a person recover hand movement.
The purpose of this study is to compare 3 non-invasive brain stimulation... expand
After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement. The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke. Type: Interventional Start Date: Jul 2023 |
Grasp-Release Assessment of a Networked Neuroprosthesis Device
Spinal Cord Injury at C5-C7 Level
Spinal Cord Injuries
Spinal Cord Injury Cervical
The overall objective of this trial is to characterize the safety and effectiveness of
the Networked Neuroprosthesis Device - Upper Extremity (NP-UE) in individuals living with
cervical SCI. expand
The overall objective of this trial is to characterize the safety and effectiveness of the Networked Neuroprosthesis Device - Upper Extremity (NP-UE) in individuals living with cervical SCI. Type: Interventional Start Date: Jan 2022 |
Study of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies
Oligoprogressive
Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of
personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with
immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI
alone in patients with oligoprogressive... expand
Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone in patients with oligoprogressive solid tumor malignancies after prior anti-cancer therapy. Type: Interventional Start Date: Jul 2023 |
Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival (...
Traumatic Injury
This is a prospective, multicenter, randomized, double-blind, placebo-controlled,
parallel-group, large simple trial to investigate the efficacy and safety of a single
intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed
or suspected acute major bleeding and /... expand
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion. Type: Interventional Start Date: Mar 2023 |
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients...
Extensive Stage Small Cell Lung Cancer
This is a randomized, open-label study of Serplulimab plus chemotherapy
(Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously
untreated US patients with ES-SCLC.
Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows:
- Arm A (Serplulimab):... expand
This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: - Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) - Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide) Type: Interventional Start Date: Nov 2022 |
The GUARDIAN Trial
Blood Pressure
The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain
intraoperative MAP ≥85 mmHg (tight pressure management); or, 2) routine intraoperative
blood pressure management (routine pressure management). expand
The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management (routine pressure management). Type: Interventional Start Date: Jul 2021 |
Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer
Pancreatic Adenosquamous Carcinoma
Resectable Pancreatic Adenocarcinoma
Pancreatic Cancer
This phase III trial compares perioperative chemotherapy (given before and after surgery)
versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer
that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as
fluorouracil, irinotecan, leucovorin,... expand
This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly). Type: Interventional Start Date: Jul 2020 |
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic...
Castration Levels of Testosterone
Metastatic Prostatic Adenocarcinoma
Stage IV Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
This phase III trial studies how well standard systemic therapy with or without
definitive treatment (prostate removal surgery or radiation therapy) works in treating
participants with prostate cancer that has spread to other places in the body. Addition
of prostate removal surgery or radiation therapy... expand
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading. Type: Interventional Start Date: Sep 2018 |
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel,...
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
HER2-Negative Breast Carcinoma
Hormone Receptor-Positive Breast Carcinoma
Localized Breast Carcinoma
This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual
chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint
Ultrahigh (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer.
Immunotherapy with monoclonal antibodies,... expand
This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint Ultrahigh (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint Ultrahigh Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. Type: Interventional Start Date: Nov 2023 |
Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed,...
Lung Adenocarcinoma
Lung Large Cell Carcinoma
Lung Non-Squamous Non-Small Cell Carcinoma
Stage III Lung Cancer AJCC v8
This phase II trial tests whether TRC102 (methoxyamine hydrochloride) in combination
usual care treatment comprised of pemetrexed, cisplatin or carboplatin, and radiation
therapy followed by durvalumab works better than the usual care treatment alone to shrink
tumors in patients with stage III non-squamous... expand
This phase II trial tests whether TRC102 (methoxyamine hydrochloride) in combination usual care treatment comprised of pemetrexed, cisplatin or carboplatin, and radiation therapy followed by durvalumab works better than the usual care treatment alone to shrink tumors in patients with stage III non-squamous non-small cell lung cancer (NSCLC). TRC102 is in a class of drugs called antineoplastic agents. It blocks the ability of a cell to repair damage to its DNA and may kill cancer cells. It may also help some anticancer drugs work better. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill cancer cells. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Giving TRC102 in combination with usual care treatment may be more effective than usual care treatment alone in stabilizing and lengthening survival time in patients with stage III non-squamous NSCLC. Type: Interventional Start Date: Dec 2022 |
RA-PRO PRAGMATIC TRIAL
Rheumatoid Arthritis
The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality
evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose
among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab)
or a targeted synthetic DMARD arm... expand
The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm (tsDMARD; choose among existing medications, currently, tofacitinib, baricitinib, upadacitinib) in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic, i.e., a second TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and/or physician experience and habit (TNFis launched 22 yrs ago vs. the first tsDMARD 8 years ago vs. first non-TNF-biologic launched 17 years ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic. Type: Interventional Start Date: Sep 2021 |