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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Drug: Abatacept; Other: Methotrexate Placebo; Other: Abatacept Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02504268

IM101-550

2015-001275-50 (EudraCT Number)

Details and patient eligibility

About

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

Full description

Subcutaneous (SC)

Enrollment: 994 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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994 participants in 4 patient groups, including a placebo group

Combination Therapy: Abatacept + Methotrexate

Experimental group

Description:

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

Treatment:

Drug: Abatacept

Drug: Methotrexate

Methotrexate treatment

Active Comparator group

Description:

Methotrexate at least 15mg per week tablet or capsule orally

Treatment:

Drug: Methotrexate

Abatacept Placebo

Placebo Comparator group

Description:

Placebo for Abatacept subcutaneous injection once per week

Treatment:

Other: Abatacept Placebo

Methotrexate Placebo

Placebo Comparator group

Description:

Placebo to match Methotrexate capsule orally once per week

Treatment:

Other: Methotrexate Placebo