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Bruton's Tyrosine Kinase (BTK) Inhibitor

branebrutinib for Rheumatoid Arthritis

Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights

Study Summary

This trial is testing a new drug, branebrutinib, to see if it is safe and effective for treating Lupus, Sjögren's Syndrome, or Rheumatoid Arthritis.

Eligible Conditions
  • Sjögren's Syndrome
  • Autoimmune Disorders
  • Rheumatoid Arthritis
  • Lupus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of Participants With ACR50 Response at Week 12 Compared to Baseline - RA
The Percent of Participants With Composite Response at Week 24 - pSS
The Percent of Participants With mCLASI Response at Week 24 and Corticosteroid (CS) < 10 mg/Day at Week 20 and Week 24 - SLE
Secondary outcome measures
Change From Baseline in CDAI at Week 12 - RA
Change From Baseline in DAS28-CRP at Week 12 - RA
Change From Baseline in DAS28-ESR at Week 12 - RA
+5 more

Side effects data

From 2022 Phase 2 trial • 119 Patients • NCT04186871
1%
Headache
1%
Bronchitis
1%
Diarrhoea
1%
Nasopharyngitis
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
RA Abatacept
RA- Branebrutinib
SLE- Placebo
SLE- Branebrutinib
pSS- Placebo
pSS- Branebrutinib
RA- Placebo

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Systemic Lupus Erythematosus (SLE): branebrutinibExperimental Treatment1 Intervention
Group II: Rheumatoid Arthritis (RA): branebrutinib followed by abataceptExperimental Treatment2 Interventions
Group III: Primary Sjögren's Syndrome (pSS): branebrutinibExperimental Treatment1 Intervention
Group IV: pSS: placeboPlacebo Group1 Intervention
Group V: SLE: placeboPlacebo Group1 Intervention
Group VI: RA: placebo followed by abataceptPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
branebrutinib
2020
Completed Phase 2
~120
abatacept
2006
Completed Phase 4
~1180

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,645 Previous Clinical Trials
4,130,880 Total Patients Enrolled
108 Trials studying Rheumatoid Arthritis
371,421 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment limited to senior citizens, or will younger patients be considered?

"The age range for this trial is 18 to 75 years old."

Answered by AI

What are some of the main health concerns that branebrutinib has been shown to improve?

"branebrutinib, while primarily used to treat rheumatoid arthritis can also help patients with psoriatic arthritis, polyarticular juvenile idiopathic arthritis and severe juvenile idiopathic arthritis."

Answered by AI

Is branebrutinib safe for long-term use?

"Since this is a phase 2 trial, meaning that there is only some data supporting safety and none confirming efficacy, our team at Power has given branebrutinib a score of 2 in terms of safety."

Answered by AI

How many people fit the bill to take part in this research?

"One hundred and eighty-five patients that meet the given inclusion criteria are required to enroll in this trial. This research is being conducted at various sites, such as Pmg Research Of Salisbury in Spokane, Washington and Arthritis Northwest Rheumatology in Salisbury, North carolina."

Answered by AI

Is this experiment being conducted across multiple hospitals in North America?

"At this time, patients are being accepted at the following trial sites: Pmg Research Of Salisbury in Spokane, Washington, Arthritis Northwest Rheumatology in Salisbury, North carolina, TriWest Research Associates in Grand Blanc, Michigan. In addition, there are 51 other potential locations for this study."

Answered by AI

What is the scientific evidence supporting branebrutinib's efficacy?

"Branebrutinib was first studied over a decade ago, in 2007. Out of the 101 trials completed, 37 are still ongoing; many of these active studies take place in Spokane, Washington."

Answered by AI

Are there presently any open slots for new volunteers in this trial?

"That is correct, the information available on clinicaltrials.gov points to this study presently recruiting participants. This trial was first posted on January 7th 2020 and updated as recently as November 11th 2022. The goal is to have 185 patients between 51 different sites."

Answered by AI

Who does this research apply to?

"This study, which is looking for a total of 185 participants, requires that patients have a diagnosis of rheumatoid arthritis and are between 18-75 years old."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis
2020. "Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04186871.
~22 spots leftby May 2025
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