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Clinical Trials/NCT02504268
NCT02504268CompletedPhase 3

A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive

Bristol-Myers Squibb91 sites in 5 countries994 target enrollmentStarted: September 3, 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
994
Locations
91
Primary Endpoint
Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24

Study Overview

Brief Summary

The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.

Detailed Description

Subcutaneous (SC)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Rheumatoid arthritis (RA) diagnosis less than 6 months
  • CRP > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h
  • At least 3 swollen and 3 tender joints
  • Anti-citrullinated protein antibodies (ACPA) positive

Exclusion Criteria

  • At risk for tuberculosis
  • Have acute infection
  • Have chronic or recurrent bacterial or serious latent viral infection
  • History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma
  • Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD)

Arms & Interventions

Combination Therapy: Abatacept + Methotrexate

Experimental

Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week

Intervention: Abatacept (Drug)

Combination Therapy: Abatacept + Methotrexate

Experimental

Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week

Intervention: Methotrexate (Drug)

Methotrexate treatment

Active Comparator

Methotrexate at least 15mg per week tablet or capsule orally

Intervention: Methotrexate (Drug)

Abatacept Placebo

Placebo Comparator

Placebo for Abatacept subcutaneous injection once per week

Intervention: Abatacept Placebo (Other)

Methotrexate Placebo

Placebo Comparator

Placebo to match Methotrexate capsule orally once per week

Intervention: Methotrexate Placebo (Other)

Outcomes

Primary Outcomes

Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24

Time Frame: Week 24

Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI \<= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI \<= 3.3 indicates disease remission and SDAI \>26 = high disease activity.

Secondary Outcomes

  • Percentage of Participants in SDAI Remission at Week 52(Week 52)
  • Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52(Week 52)
  • Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24(Week 24)
  • Percentage of Participants in Boolean Remission at Week 52(Week 52)

Investigators

Sponsor
Bristol-Myers Squibb
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (91)

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