Trial Summary
What is the purpose of this trial?Rheumatoid arthritis is a disabling arthritis that affects young women disproportionately. Although the physicians have some excellent treatments, they do not know which treatment is best for which patient. The investigators want to find ways to identify the right drug for the right patient at the right time. This is what personalized medicine is all about.
What safety data is available for personalized arthritis medication for rheumatoid arthritis?The safety data for personalized arthritis medication, including JAK inhibitors like tofacitinib, baricitinib, upadacitinib, and filgotinib, shows that these drugs have a class effect of adverse events. Serious infections occur at rates similar to other advanced therapies for rheumatoid arthritis, but there is a higher incidence of herpes zoster reactivation. Tofacitinib has shown higher adverse event rates compared to TNF inhibitors like adalimumab or etanercept. Management of adverse events is challenging due to the lack of robust data and the variability of events, requiring careful clinical decision-making and collaboration among specialists.45789
What data supports the idea that Personalized Arthritis Medication for Rheumatoid Arthritis is an effective drug?The available research shows that Personalized Arthritis Medication, specifically Janus kinase inhibitors (JAKi) like tofacitinib, baricitinib, upadacitinib, and filgotinib, can be effective for people with rheumatoid arthritis who haven't responded well to other treatments. For example, a study found that tofacitinib, when combined with methotrexate, improved patient-reported outcomes over 24 months. However, it's important to note that some patients experienced more side effects with JAK inhibitors compared to other drugs like TNFi. This suggests that while JAK inhibitors can be effective, they may not be suitable for everyone due to potential side effects.16789
Do I have to stop my current medications for this trial?The protocol does not specify if you need to stop your current medications. However, if you are on certain b/tsDMARDs, you may not be eligible for some parts of the study.
Is the drug Anti-IL6, JAKi, TNFi a promising treatment for rheumatoid arthritis?Yes, the drug Anti-IL6, JAKi, TNFi, which includes tofacitinib and other Janus kinase inhibitors, is promising for treating rheumatoid arthritis. It helps reduce joint inflammation and damage, improving patient outcomes.12368
Eligibility Criteria
The SUPRA trial is for adults over 18 with Rheumatoid Arthritis who haven't improved after standard treatments. It's split into two parts: one for those needing a second-line treatment, and another for those where TNF inhibitors didn't work. Participants must be able to consent and fill out forms in English or French.Inclusion Criteria
I have been diagnosed with rheumatoid arthritis according to the 2010 criteria.
I am 18 years old or older.
Exclusion Criteria
I have another inflammatory condition like lupus that needs specific treatment.
I cannot take certain arthritis medications due to an active infection, current cancer, severe organ issues, history of blood clots (unless I'm on blood thinners), high risk of heart disease, or because I am pregnant/breastfeeding.
Treatment Details
This study tests different drugs (TNFi, JAKi, Anti-IL6) to find the best personalized treatment for Rheumatoid Arthritis patients. The goal is to match the right drug to each patient based on their specific needs at the correct time.
4Treatment groups
Active Control
Group I: Sub-study 1 TNFiActive Control1 Intervention
TNFi - any sub-cutaneous (sc) formulation, namely etanercept (receptor fusion protein), adalimumab (monoclonal antibody), golimumab (monoclonal antibody), or certolizumab (pegylated fragment of a monoclonal antibody)
Group II: Sub-study 2 JAKiActive Control1 Intervention
JAKi - tofacitinib (JAK1/3 inhibitor), baricitinib (JAK 1/2 inhibitor) or upadacitinib (JAK1 inhibitor)
Group III: Sub-study 1 Anti-IL6Active Control1 Intervention
Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab
Group IV: Sub-study 2 Anti-IL6Active Control1 Intervention
Anti-IL6 receptor monoclonal antibodies - tocilizumab or sarilumab
Anti-IL6 is already approved in European Union, United States, European Union, United States for the following indications:
πͺπΊ Approved in European Union as Tocilizumab for:
- Rheumatoid arthritis
- Giant cell arteritis
- Polyarticular or systemic juvenile idiopathic arthritis
- Cytokine release syndrome
πΊπΈ Approved in United States as Actemra for:
- Moderately to severely active rheumatoid arthritis
- Giant cell arteritis
- Polyarticular or systemic juvenile idiopathic arthritis
- Cytokine release syndrome
πͺπΊ Approved in European Union as Sarilumab for:
- Moderately to severely active rheumatoid arthritis
πΊπΈ Approved in United States as Kevzara for:
- Moderately to severely active rheumatoid arthritis
Find a clinic near you
Research locations nearbySelect from list below to view details:
Sir Mortimer B. Davis Jewish General HospitalMontreal, Canada
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Who is running the clinical trial?
Marie Hudson, MDLead Sponsor
Lady Davis InstituteCollaborator
Montreal General HospitalCollaborator
McGill University Health Centre/Research Institute of the McGill University Health CentreCollaborator
References
Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. [2022]Rheumatoid arthritis is a heterogeneous chronic disease, and no therapeutic agent has been identified which is universally and persistently effective in all patients. We investigated the effectiveness of tofacitinib (CP-690,550), a novel oral Janus kinase inhibitor, as a targeted immunomodulator and disease-modifying therapy for rheumatoid arthritis.
Efficacy and safety of tofacitinib for treatment of rheumatoid arthritis. [2022]Tofacitinib is the first in a new class of nonbiologic disease-modifying antirheumatic drugs (DMARDs), a targeted, synthetic DMARD, approved for the treatment of rheumatoid arthritis (RA) as monotherapy or in combination with methotrexate or other non-biologic DMARD. Tofacitinib, an orally administered Janus kinase (JAK) inhibitor, decreases T-cell activation, pro-inflammatory cytokine production, and cytokine signaling by inhibiting binding of type I cytokine receptors family and Ξ³-chain cytokines to paired JAK1/JAK3 receptors. The net effect of tofacitinb's mechanism of action is decreased synovial inflammation and structural joint damage in RA patients. To date, six phase 3 trials have been conducted to evaluate the safety and efficacy of tofacitinib under the oral rheumatoid arthritis triaLs (ORAL) series. This review describes the pharmacology of the novel agent, tofacitinib, and details the safety and efficacy data of the ORAL trials.
Effectiveness and safety of tofacitinib in rheumatoid arthritis: a cohort study. [2019]Tofacitinib is the first oral Janus kinase inhibitor approved for the treatment of rheumatoid arthritis (RA). We compared the effectiveness and safety of tofacitinib, disease-modifying antirheumatic drugs (DMARDs), tumor necrosis factor inhibitors (TNFi), and non-TNF biologics in patients with RA previously treated with methotrexate.
Adverse events, clinical considerations and management recommendations in rheumatoid arthritis patients treated with JAK inhibitors. [2021]A new class of oral synthetic drugs has been developed for the treatment of rheumatoid arthritis (RA) with the aim of blocking the Janus kinase/signal transducer and activator of transcription (JAK-STAT) system. Tofacitinib and baricitinib have been approved for the treatment RA patients who inadequately respond to methotrexate or anti-tumor necrosis factor drugs. The aim of this narrative review is to summarize the data concerning the drugs' basic mechanisms and clinical trial results in order to inform clinicians about the serious and non-serious adverse events associated with JAK inhibitors. Areas covered: The mechanisms, adverse events, and clinical trial data associated with the use of JAK inhibitors in RA patients were reviewed by searching the PubMed, Medline, and Cochrane Library databases for papers published between 1999 and April 2018 using combinations of words or terms. Articles not written in English were excluded. Expert commentary: Management of the adverse events of JAK inhibitors is challenging because of the lack of robust treatment data used and the heterogeneity of the events themselves. Treatment decisions are often made clinically on the basis of age and the burden of comorbidities, and require the multidisciplinary collaboration of rheumatologists and other specialists.
Comparison of Janus kinase inhibitors in the treatment of rheumatoid arthritis: a systemic literature review. [2020]Several Janus kinase (JAK) inhibitors, oral targeted disease-modifying drugs, will be approved for the treatment of rheumatoid arthritis (RA) and other diseases. This review compares and contrasts the efficacy of JAK inhibitors (tofacitinib, baricitinib, upadacitinib, filgotinib, peficitinib and decernotinib) in RA including: early RA methotrexate-naive patients, post methotrexate failure and post biologics. Trials in monotherapy, combination with disease modifying drugs such as methotrexate, and comparing with adalimumab in biologic-naive patients were studied. The efficacy is superior to methotrexate in naive patients and equal or superior to adalimumab depending on the drug and dose. There is a class effect of adverse events. Serious infections occur at a rate similar to other advanced therapies in RA, although more reactivation of herpes zoster occurs.
Tofacitinib in combination with methotrexate in patients with rheumatoid arthritis: patient-reported outcomes from the 24-month Phase 3 ORAL Scan study. [2022]Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we present data from the completed Phase 3 randomised controlled trial (RCT) ORAL Scan (NCT00847613), which evaluated the impact of tofacitinib on patient-reported outcomes (PROs) through 24 months in patients with active RA and inadequate responses to methotrexate (MTX-IR).
Current jakinibs for the treatment of rheumatoid arthritis: a systematic review. [2021]One-third of patients with severe rheumatoid arthritis (RA) do not achieve remission or low disease activity, or they have side effects from cDMARD and bDMARD. They will need a new treatment option such as the small molecule JAK inhibitors. In this systematic review, we evaluate the efficacy and safety data of the current jakinibs: tofacitinib, peficitinib, decernotinib, upadacitinib, baricitinib and filgotinib in patients in whom treatment with conventional or biological disease-modifying antirheumatic drugs (cDMARD and/or bDMARD) failed.
Are all JAK inhibitors for the treatment of rheumatoid arthritis equivalent? An adjusted indirect comparison of the efficacy of tofacitinib, baricitinib, upadacitinib, and filgotinib. [2023]Comparisons of Janus kinase inhibitors (JAKi) for treatment of rheumatoid arthritis in patients with inadequate response to biologic disease-modifying anti-rheumatic drugs are lacking. We assessed the relative efficacy and safety of four JAKi (tofacitinib, baricitinib, upadacitinib, and filgotinib) in this context.
Evaluation of discontinuation for adverse events of JAK inhibitors and bDMARDs in an international collaboration of rheumatoid arthritis registers (the 'JAK-pot' study). [2023]In a clinical trial setting, patients with rheumatoid arthritis (RA) taking the Janus kinase inhibitor (JAKi) tofacitinib demonstrated higher adverse events rates compared with those taking the tumour necrosis factor inhibitors (TNFi) adalimumab or etanercept.