Methotrexate - Inadequate Response Device Sub-Study (MTX-IR)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis (RA)

Treatments: Device: Abatacept combination product (ACP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01173120

IM101-174 (Sub study)

2007-005434-37 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the safety and acceptability of a device used in place of traditional syringes for abatacept self-injection.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women, ages ≥ 18
• Participants who are considered methotrexate inadequate responders (MTX-IR)
• 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)
• Participants were to have been enrolled in the main MTX-IR study and been treated with open label abatacept for at least 3 months in the long term period

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Abatacept Combination Product (ACP)

Experimental group

Description:

Participants from the long-term period of study NCT00559585 who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a pre-filled liquid product device delivering 125 mg abatacept/device (125 mg/mL).

Treatment:

Device: Abatacept combination product (ACP)