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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00254293
Date of registration: 15/11/2005
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)
Scientific title: A Study to Assess the Steady-State Trough Serum Concentration, Safety, and Immunogenicity of Abatacept (BMS-188667) Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Who Are Receiving Disease Modifying Ant-Rheumatic Drugs (DMARDs)
Date of first enrolment: January 2006
Target sample size: 87
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00254293
Study type:  Interventional
Study design:   
Phase:  Phase 1/Phase 2
Countries of recruitment
United States
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Drug: Abatacept or Placebo (both as IV & SC Solution)
Primary Outcome(s)
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE) [Time Frame: Day 85 to 56 days post last dose]
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing) [Time Frame: Day 533 to 56 Days Post last dose]
Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE) [Time Frame: Day 85 to Day 533]
Short Term Period: Steady-state Trough Serum Concentration (Cmin) of Abatacept Following Weekly Subcutaneous Dosing in Participants With Active Rheumatoid Arthritis Receiving Disease Modifying Anti-rheumatic Drugs (DMARDS) [Time Frame: Days 71 to 85]
Secondary Outcome(s)
Overall Study ST and LTE Periods: Number of Participants With Anti-abatacept Antibodies and/or Anti-cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibodies [Time Frame: ST: Day 1 to Day 85; LTE: Day 85 to 168 days post last dose]
Short Term Period: Area Under the Curve (AUC) in Time Interval of 7 Days [AUC(TAU)] of Abatacept in Participants With Rheumatoid Arthritis Receiving DMARDS [Time Frame: Day 71 to Day 78]
Short Term Period: Mean Change From Baseline at Day 85 in Blood Pressure After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS [Time Frame: Day 1 to Day 85 (or early termination)]
Short Term Period: Mean Change From Baseline at Day 85 in Pulse Rate After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS [Time Frame: Day 1 to Day 85 (or early termination)]
Short Term Period: Mean Change From Screening at Day 85 in ECG (Heart Rate) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS [Time Frame: Screening to Day 85 (or early termination)]
Short Term Period: Mean Change From Screening to Day 85 in Electrocardiogram (QT, PR Intervals, QRS Width) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS [Time Frame: Screening to Day 85 (or early termination)]
Short Term Period: Mean Percent Change From Baseline on Day 85 in Participants Positive for Serum Rheumatoid Factor During Abatacept or Placebo Administration [Time Frame: Day 1 to Day 85 (or early termination)]
Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85) [Time Frame: Day 1 to Day 85 (or early termination)]
Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85 [Time Frame: Day 1 to Day 85 (or early termination)]
Short Term Period: Number of Participants With Pre-specified Adverse Events (AEs) of Special Interest After Administration of Abatacept or Placebo Over 12 Weeks [Time Frame: Day 1 to Day 85 (or early termination)]
Short Term Period: Peak Serum Concentration (Cmax) of Abatacept at Steady State in Participants With Rheumatoid Arthritis Receiving DMARDS [Time Frame: Day 71 to Day 78]
Short Term Period: Summary of Adverse Events (AEs), Serious AEs, Deaths, and Discontinuations Due to AEs During 12 Weeks of Treatment With Either Abatacept or Placebo [Time Frame: Day 1 to Day 85 (or early termination)]
Secondary ID(s)
IM101-063
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 08/04/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00254293
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