Methotrexate - Inadequate Response Device Sub-Study

NCT ID: NCT01173120

Last Updated: 2012-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-07-31

Brief Summary

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.

Conditions

Rheumatoid Arthritis (RA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abatacept Combination Product (ACP)

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).

Group Type: EXPERIMENTAL

Abatacept combination product (ACP)

Intervention Type: DEVICE

Abatacept Solution, Subcutaneous, 125 mg/device, Weekly, 3 months

Interventions

Abatacept combination product (ACP)

Abatacept Solution, Subcutaneous, 125 mg/device, Weekly, 3 months

Intervention Type: DEVICE

Other Intervention Names

Orencia; BMS-188667

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Other Identifiers

2007-005434-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM101-174 (Sub study)

Identifier Type: -

Identifier Source: org_study_id