Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Abatacept or Placebo (both as IV & SC Solution); Drug: Abatacept; Drug: Abatacept or Placebo (both as IV & SC solution)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254293

IM101-063

Details and patient eligibility

About

The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in subjects with RA.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet ARA criteria for diagnosis of RA with active disease.
• RA diagnosis for at least 1 year.
• > = 6 swollen joints.
• > = 8 tender joints.
• Taking methotrexate (MTX) or MTX plus not more than 1 added oral DMARD for > = 3 months and stable for 28 days prior to dosing.

Exclusion criteria

• Serious acute or bacterial infection in last 3 months.
• Chronic or recurrent bacterial infections.
• History of TB within previous 3 years or old TB not adequately treated.
• Specific lab test abnormalities
• History of cancer within 5 years.
• Exposure to CTLA4Ig (Cytotoxic T-lymphocyte (T-cell)-associated antigen 4Ig), belatacept, rituximab, efalizumab, alefacept, or other investigational drug or biologic.
• Treatment with hydroxychloroquine, azathioprine, leflunomide, immunoadsorption columns, mycophenolate mofetil, cyclosporine, D-Penicillamine or calcineurin inhibitors.
• Exposure to live vaccines.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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87 participants in 6 patient groups, including a placebo group

Group 1 (weight < 60 kg)

Placebo Comparator group

Treatment:

Drug: Abatacept or Placebo (both as IV & SC Solution)

Drug: Abatacept or Placebo (both as IV & SC Solution)

Group 2 (weight < 60 kg)

Placebo Comparator group

Treatment:

Drug: Abatacept or Placebo (both as IV & SC Solution)

Drug: Abatacept or Placebo (both as IV & SC Solution)

Group 3 (weight 60-100 kg)

Placebo Comparator group

Treatment:

Drug: Abatacept or Placebo (both as IV & SC solution)

Drug: Abatacept or Placebo (both as IV & SC solution)

Drug: Abatacept or Placebo (both as IV & SC solution)

Group 4 (weight > 100 kg)

Placebo Comparator group

Treatment:

Drug: Abatacept or Placebo (both as IV & SC solution)

Drug: Abatacept or Placebo (both as IV & SC solution)

Drug: Abatacept or Placebo (both as IV & SC solution)

Group 5 (weight > 100 kg)

Placebo Comparator group

Treatment:

Drug: Abatacept or Placebo (both as IV & SC solution)

Drug: Abatacept or Placebo (both as IV & SC solution)

Drug: Abatacept or Placebo (both as IV & SC solution)

Abatacept

Experimental group

Description:

Long Term

Treatment:

Drug: Abatacept