Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sj gren's Syndrome or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis

  • End date
    Feb 10, 2023
  • participants needed
  • sponsor
    Bristol-Myers Squibb
Updated on 22 September 2021
sjogren's syndrome
progressive systemic sclerosis


The purpose of this study is to evaluate the safety and effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjgren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participants with active Rheumatoid Arthritis (RA).

Condition Autoimmune disease, CONNECTIVE TISSUE DISEASE, Rheumatoid Arthritis, SYSTEMIC LUPUS ERYTHEMATOSUS, Autoimmunity, Rheumatoid Arthritis (Pediatric), Dermatomyositis (Connective Tissue Disease), Connective Tissue Diseases, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, autoimmune diseases, autoimmune disorder, autoimmune disorders, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome, Primary Sjögren's Syndrome
Treatment Abatacept, branebrutinib, branebrutinib placebo
Clinical Study IdentifierNCT04186871
SponsorBristol-Myers Squibb
Last Modified on22 September 2021


Yes No Not Sure

Inclusion Criteria

Sub-study for Systemic Lupus Erythematosus (SLE)
Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) classification
Diagnosed with SLE more than 24 weeks before screening visit
Sub-study for primary Sjgren's Syndrome (pSS)
Moderate to severe pSS, meeting ACR-EULAR classification criteria
Sub-study for active Rheumatoid Arthritis (RA)
Moderate to severe adult-onset RA
ACR global functional status class I to III
Women and men must agree to follow instructions for methods of contraception

Exclusion Criteria

Sub-study for Systemic Lupus Erythematosus
Certain other autoimmune diseases and overlap syndromes
Sub-study for primary Sjgren's Syndrome
Certain other immune-mediated diseases, active fibromyalgia, or other medical conditions
Sub-study for Rheumatoid Arthritis (RA)
Diagnosis with juvenile arthritis or idiopathic arthritis before age 16
For all sub-studies
History of any significant drug allergy
Active infection, significant concurrent medical condition, or clinically significant abnormalities
Other protocol defined inclusion/exclusion criteria could apply
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note