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Effects of Abatacept in Patients With Early Rheumatoid Arthritis (AVERT-2)

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ClinicalTrials.gov Identifier: NCT02504268
Recruitment Status : Active, not recruiting
First Posted : July 21, 2015
Results First Posted : April 8, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE July 20, 2015
First Posted Date  ICMJE July 21, 2015
Results First Submitted Date  ICMJE January 16, 2019
Results First Posted Date  ICMJE April 8, 2019
Last Update Posted Date November 27, 2019
Actual Study Start Date  ICMJE August 31, 2015
Actual Primary Completion Date January 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
Percentage of Subjects 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
Proportion of subjects in Simple Disease Activity Index (SDAI) remission [ Time Frame: Week 24 ]
Change History Complete list of historical versions of study NCT02504268 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
  • Percentage of Subjects in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24 [ Time Frame: Week 24 ]
    DAS28-CRP = Disease Activity Score 28 based on C-reactive protein DAS28-CRP Remission is defined as DAS28-CRP <= 2.6 Using a logistic regression model that includes treatment arm, stratification variable and baseline measure as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided.
  • Percentage of Subjects in SDAI Remission at Week 52 [ Time Frame: Week 52 ]
    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.
  • 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 [ Time Frame: Week 52 ]
    The Modified Total Sharp Score (mTSS) is calculated as the bilateral sum of erosion and Joint Space Narrowing (JSN) scores across all joints of the hands and feet.The score range for mTSS is 0-448. Higher scores indicate more joint damage. The mean change from baseline in TSS using modified Sharp/van der Heijide scores was assessed using a rank-based nonparametric ANCOVA model.
  • Percentage of Subjects in Boolean Remission at Week 52 [ Time Frame: Week 52 ]
    Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). Logistic regression was used for this endpoint.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
  • Proportion of subjects in Disease Activity Index (DAS)28 - c-reactive protein (CRP) remission [ Time Frame: Week 52 ]
  • Proportion of subjects in SDAI remission [ Time Frame: Week 52 ]
  • Mean change from baseline in radiographic progression of joint damage [ Time Frame: Week 52 ]
  • Proportion of subjects in Boolean remission [ Time Frame: Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Abatacept in Patients With Early Rheumatoid Arthritis
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Abatacept
  • Drug: Methotrexate
  • Other: Abatacept Placebo
  • Other: Methotrexate Placebo
Study Arms  ICMJE
  • Experimental: Combination Therapy: Abatacept + Methotrexate
    Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
    Interventions:
    • Drug: Abatacept
    • Drug: Methotrexate
  • Active Comparator: Methotrexate treatment
    Methotrexate at least 15mg per week tablet or capsule orally
    Intervention: Drug: Methotrexate
  • Placebo Comparator: Abatacept Placebo
    Placebo for Abatacept subcutaneous injection once per week
    Intervention: Other: Abatacept Placebo
  • Placebo Comparator: Methotrexate Placebo
    Placebo to match Methotrexate capsule orally once per week
    Intervention: Other: Methotrexate 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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 4, 2019)
1067
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2015)
1000
Estimated Study Completion Date  ICMJE March 20, 2020
Actual Primary Completion Date January 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Brazil,   Canada,   Chile,   Colombia,   Czechia,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Monaco,   Netherlands,   Peru,   Poland,   Qatar,   Romania,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Puerto Rico,   Saudi Arabia,   United Arab Emirates
 
Administrative Information
NCT Number  ICMJE NCT02504268
Other Study ID Numbers  ICMJE IM101-550
2015-001275-50 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date November 2019

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