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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 : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Abatacept Drug: Methotrexate Other: Abatacept Placebo Other: Methotrexate Placebo Phase 3

Detailed Description:
Subcutaneous (SC)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1067 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 31, 2015
Actual Primary Completion Date : January 16, 2017
Estimated Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Abatacept
Drug: Methotrexate
Active Comparator: Methotrexate treatment
Methotrexate at least 15mg per week tablet or capsule orally
Drug: Methotrexate
Placebo Comparator: Abatacept Placebo
Placebo for Abatacept subcutaneous injection once per week
Other: Abatacept Placebo
Placebo Comparator: Methotrexate Placebo
Placebo to match Methotrexate capsule orally once per week
Other: Methotrexate Placebo



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504268


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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02504268     History of Changes
Other Study ID Numbers: IM101-550
2015-001275-50 ( EudraCT Number )
First Posted: July 21, 2015    Key Record Dates
Results First Posted: April 8, 2019
Last Update Posted: August 6, 2019
Last Verified: August 2019

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abatacept
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors