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NCT04186871 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
119
Enrollment target
20
Study locations

NCT04186871: Completed Phase 2 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, sponsored by Bristol-Myers Squibb.

NCT04186871 is a Phase 2 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 119 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04186871, a Phase 2 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
119 participants
Enrollment target
20
Study locations

Study Summary

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 Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participants with active Rheumatoid Arthritis (RA).

Primary Outcome

mCLASI response is defined as a decrease of ≥ 50% from baseline mCLASI activity score, in participants with a baseline mCLASI activity score ≥ 10, at Week 24. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment. To be considered as meeting the second criterion, the CS (prednisone or equivalent) dose had to remain stable and ≤ 10 mg from Week 16 until Week 24. The modified CLASI (mCLASI) is defined as the activity portions of CLASI that describe s

Conditions Studied

Rheumatoid Arthritis Systemic Lupus Erythematosus Primary Sjögren's Syndrome Autoimmune Disorder

Interventions

  • DRUG abatacept
  • DRUG branebrutinib
  • DRUG branebrutinib placebo

Study Locations (20)

Florida

  • Local Institution - Brandon
  • Local Institution - 0062 - DeBary
  • Local Institution - 0035 - Hialeah
  • Local Institution - Jacksonville
  • Local Institution - 0029 - Plantation

California

  • Local Institution - 0002 - Covina
  • Local Institution - 0024 - Encino
  • Local Institution - 0034 - San Diego
  • Local Institution - 0032 - Upland

Michigan

  • Local Institution - 0041 - Ann Arbor
  • Local Institution - 0082 - Grand Blanc

Missouri

  • Local Institution - 0096 - St Louis
  • Local Institution - 0040 - St Louis

Arizona

  • Local Institution - 0019 - Phoenix

Georgia

  • Local Institution - 0009 - Lawrenceville

Illinois

  • Local Institution - 0014 - Skokie

Indiana

  • Local Institution - Evansville

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2020-01-07
Est. Completion 2022-12-05
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What the finished NCT04186871 record still lists

NCT04186871 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (97% lower).

The record links to 4 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 3 interventions - of which abatacept is the first listed.

NCT04186871 names 20 study sites across 11 states, led by Florida, California, Michigan.

Frequently Asked Questions

What is clinical trial NCT04186871 about?

NCT04186871 is a clinical study titled "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". 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 Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participa...

What is the current status of trial NCT04186871?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2020-01-07. Estimated completion is 2022-12-05.

What conditions does trial NCT04186871 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis, Systemic Lupus Erythematosus, Primary Sjögren's Syndrome, Autoimmune Disorder.

What interventions are being tested in trial NCT04186871?

The interventions under investigation include: abatacept (DRUG), branebrutinib (DRUG), branebrutinib placebo (DRUG).

Who is sponsoring clinical trial NCT04186871?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04186871 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04186871's enrollment target sits among peer trials

119 112th of 197 higher than 86 of 197 other Rheumatoid Arthritis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04186871, the US trial registry maintained by the National Library of Medicine. NCT04186871 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.