Branebrutinib + Abatacept for Rheumatoid Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called branebrutinib to determine its safety and effectiveness for individuals with certain immune system conditions. It targets those with active systemic lupus erythematosus (SLE), primary Sjögren's syndrome (pSS), or rheumatoid arthritis (RA). Participants with RA will also receive a second treatment, abatacept (Orencia), following branebrutinib. Ideal participants are those diagnosed with active SLE, moderate to severe pSS, or moderate to severe adult-onset RA, with these conditions significantly impacting their daily life. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that branebrutinib is generally well-tolerated. Most side effects are mild or moderate, with only one serious side effect leading a participant to stop treatment. Compared to similar drugs, branebrutinib typically causes fewer skin rashes, making it gentler on the body.
For those with rheumatoid arthritis, the study includes two treatments: first branebrutinib, then abatacept. The FDA has already approved abatacept for treating rheumatoid arthritis, confirming its safety. Studies comparing abatacept to a placebo (a treatment with no active ingredients) found similar side effects in both groups, indicating its general safety.
Overall, research suggests that both treatments are quite safe for most people.12345Why are researchers excited about this trial's treatments?
Branebrutinib is unique because it targets Bruton's tyrosine kinase (BTK), a different approach compared to traditional treatments like corticosteroids or hydroxychloroquine for systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS). This mechanism of action is promising because it directly interferes with the signaling pathways that contribute to the inflammation and autoimmune responses characteristic of these conditions. Additionally, for rheumatoid arthritis (RA), the study explores combining branebrutinib with abatacept, which could offer a synergistic effect by targeting both BTK and T-cell activation pathways. Researchers are excited about these treatments as they potentially offer a more targeted and effective approach with fewer side effects than current standard therapies.
What evidence suggests that this trial's treatments could be effective for SLE, pSS, and RA?
Research shows that branebrutinib may help treat several autoimmune diseases. In this trial, participants with systemic lupus erythematosus (SLE) will receive branebrutinib, which has reduced disease activity compared to a placebo. For primary Sjögren's syndrome (pSS), participants will receive either branebrutinib or a placebo, with studies suggesting that branebrutinib can ease symptoms. In the rheumatoid arthritis (RA) arm, participants will receive branebrutinib followed by abatacept, or a placebo followed by abatacept. Branebrutinib blocks a protein called BTK, which is expected to lower inflammation. Additionally, abatacept, used after branebrutinib for RA, has slowed disease progression and increased remission rates. These findings support branebrutinib's potential effectiveness for these conditions.678910
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive branebrutinib treatment for active systemic Lupus Erythematosus, Primary Sjögren's Syndrome, or Rheumatoid Arthritis, with an option for open-label abatacept treatment in RA
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants with Rheumatoid Arthritis may opt into continuation of treatment with abatacept long-term
What Are the Treatments Tested in This Trial?
Interventions
- abatacept
- branebrutinib
- branebrutinib placebo
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
The Efficacy and Safety of Abatacept in Rheumatoid Arthritis
Remission rate increased in patients treated also in year 2 from 46.1% at year 1 to 55.2% of patients at the end of year 2 [Westhovens et al. 2009f].
Efficacy Data - ORENCIA® (abatacept)
In controlled clinical trials, adult RA patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) ...
Abatacept: the evidence for its place in the treatment of ...
These results confirm that abatacept 2 mg/kg is suboptimal for effective treatment of active RA. Table 5. Response to abatacept or placebo after 1 year in ...
Abatacept in individuals at high risk of rheumatoid arthritis ...
At 24 months, 27 (25%) of 110 participants in the abatacept group had progressed to rheumatoid arthritis, compared with 38 (37%) of 103 in the ...
5.
arthritis-research.biomedcentral.com
arthritis-research.biomedcentral.com/articles/10.1186/s13075-020-2100-yAbatacept in rheumatoid arthritis: survival on drug, clinical ...
The aim of this study was to investigate clinical efficacy and tolerability of abatacept in RA, using a national register.
Safety Data | ORENCIA® (abatacept)
Concomitant use with a TNF antagonist can increase the risk of infections and serious infections. Hypersensitivity and anaphylaxis have occurred. Serious ...
ORENCIA® Side Effects & Rheumatoid Arthritis (RA) ...
ORENCIA has a well-established safety profile · Adult Rheumatoid Arthritis (RA). ORENCIA is used to reduce signs and symptoms of moderate to severe Rheumatoid ...
Safety of Abatacept Versus Placebo in Rheumatoid Arthritis
Clinical trials have also shown that abatacept is safe and well tolerated, with similar rates of adverse events (AEs) compared with placebo, demonstrating a ...
New Data Describe Safety of Subcutaneous Administration ...
Most Frequent Adverse Events (≥10 percent): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly ...
Safety of Abatacept Administered Intravenously in ...
Longterm safety of IV abatacept was consistent with the short-term, with no unexpected events and low incidence rates of serious infections, ...
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