Methotrexate-Inadequate Response Study

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis (RA)

Treatments: Drug: Subcutaneous (SC) Abatacept; Drug: Intravenous (IV) Abatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00559585

IM101-174

EUDRACT # 2007-005434-37

Details and patient eligibility

About

The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.

Enrollment: 2,492 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:

• Subjects who are considered methotrexate inadequate responders
• 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)

Exclusion Criteria:

• Subjects who failed one or multiple anti-tumor necrosis factor (TNF) therapies
• Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous)
• Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
• Subjects with severe chronic or recurrent bacterial infections
• Subjects who have received treatment with rituximab

An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,492 participants in 2 patient groups

Subcutaneous (SC) Abatacept

Active Comparator group

Description:

Participants received 125 mg weekly SC abatacept injections (with an intravenous \[IV\] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.

Treatment:

Drug: Subcutaneous (SC) Abatacept

Intravenous (IV) Abatacept

Active Comparator group

Description:

Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).

Treatment:

Drug: Intravenous (IV) Abatacept