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Trial record 35 of 38 for:    rheumatoid arthritis | bristol [Lead] | United States

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

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ClinicalTrials.gov Identifier: NCT04186871
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 28, 2019
First Posted Date  ICMJE December 5, 2019
Last Update Posted Date August 11, 2020
Actual Study Start Date  ICMJE January 7, 2020
Estimated Primary Completion Date June 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
  • SLE: mCLASI activity score response [ Time Frame: at 24 weeks ]
    Proportion of participants with a ≥ 50% reduction of mCLASI from baseline
  • pSS: Proportion of subjects with changes in a composite score that includes ESSPRI (EULAR Sjögren's Syndrome Patient Reported Index), ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index), ocular staining, salivary flow and serological marker [ Time Frame: at 24 weeks ]
    Clinically significant improvements from baseline in ESSPRI, ESSDAI, ocular staining, salivary flow, and serological marker (rheumatoid factor [RF], IgG, complement C3 or C4, cryoglobulin) used in the composite measure.
  • RA: ACR50 response [ Time Frame: at 12 weeks ]
    Proportion of participants achieving ACR50 response (American College of Rheumatology 50 criteria)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
  • SLE: SLEDAI-2K score response [ Time Frame: at 24 weeks ]
    Change from baseline in SLEDAI-2K score (Systemic Lupus Erythematosus Disease Activity Index 2000)
  • SLE: BILAG-based Composite Lupus Assessment response [ Time Frame: at 24 weeks ]
    Change from baseline in BILAG-based (British Isles Lupus Assessment Group) Composite Lupus Assessment response
  • RA: DAS28-CRP response [ Time Frame: at 12 weeks ]
    Change from baseline in DAS28-CRP (Disease Activity Score 28 - C reactive protein)
  • RA: DAS28-ESR response [ Time Frame: at 12 weeks ]
    Change from baseline in DAS28-ESR (Disease Activity Score 28 - Erythrocyte Sedimentation Rate)
  • RA: SDAI response [ Time Frame: at 12 weeks ]
    Change from baseline in SDAI (Simplified Disease Activity Index)
  • RA: CDAI response [ Time Frame: at 12 weeks ]
    Change from baseline in CDAI (Clinical Disease Activity Index)
  • RA: ACR20 response [ Time Frame: at 12 weeks ]
    Proportion of participants achieving ACR20 response (American College of Rheumatology 20 criteria)
  • RA: ACR70 response [ Time Frame: at 12 weeks ]
    Proportion of participants achieving ACR70 response (American College of Rheumatology 70 criteria)
  • SLE, pSS, RA: Safety [ Time Frame: up to 28 weeks ]
    Incidence of Serious Adverse Events, Adverse Events; number of clinically significant changes in lab assessment of blood, number of clinically significant changes in vital sign of body temperature, blood pressure, and respiratory rate; number of clinically significant changes in electrocardiogram.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis
Brief Summary Study 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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind
Primary Purpose: Treatment
Condition  ICMJE
  • Autoimmune Disorder
  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
  • Primary Sjögren's Syndrome
Intervention  ICMJE
  • Drug: branebrutinib
    specified dose on specified days
  • Drug: abatacept
    open label 125 mg once weekly
  • Drug: branebrutinib placebo
    specified dose on specified days
Study Arms  ICMJE
  • Experimental: SLE: branebrutinib
    Intervention: Drug: branebrutinib
  • Placebo Comparator: SLE: placebo
    Intervention: Drug: branebrutinib placebo
  • Experimental: pSS: branebrutinib
    Intervention: Drug: branebrutinib
  • Placebo Comparator: pSS: placebo
    Intervention: Drug: branebrutinib placebo
  • Experimental: RA: branebrutinib followed by abatacept
    Interventions:
    • Drug: branebrutinib
    • Drug: abatacept
  • Placebo Comparator: RA: placebo followed by abatacept
    Interventions:
    • Drug: abatacept
    • Drug: branebrutinib placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2019)
185
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 23, 2022
Estimated Primary Completion Date June 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

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 Sjögren'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 Sjögren'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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States,   Argentina,   Australia,   Belgium,   France,   Germany,   Mexico,   Netherlands,   Poland,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04186871
Other Study ID Numbers  ICMJE IM014-029
2019-002205-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bristol-Myers Squibb
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP