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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:  NCT00484289
Date of registration: 07/06/2007
Prospective Registration: No
Primary sponsor: Bristol-Myers Squibb
Public title: A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis
Scientific title: A Phase III, Multi-center, Open-label, Uncontrolled, Long-term Study to Evaluate the Safety of Abatacept (BMS-188667) in Japanese Subjects With Rheumatoid Arthritis Having Completed Clinical Studies IM101-071, IM101-034, and Also Special DMARD Failures
Date of first enrolment: December 2006
Target sample size: 217
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00484289
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Japan
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

Inclusion Criteria

- The participants who completed the 169 days, full study period of Phase II (IM101-071)
and were not administered other biologics between completion of IM101-071 and
registration of this long-term study.

- The participants of the Phase I study (IM101-034), who received abatacept, except
participants who were withdrawn from the study due to safety problems related to
abatacept.

- New subjects with MTX intolerance: rheumatoid arthritis (RA) patients to whom MTX
cannot be administered for safety reasons and who present an inadequate response to
disease-modifying antirheumatic drugs (DMARDs;excluding MTX) or biologics (new
subjects with MTX intolerance: RA patients who present an inadequate response to
DMARDs).

Exclusion Criteria

- Women of childbearing potential (WOCBP) who were unwilling or unable to use an
acceptable method of contraception.

- Participants who have received non approved or investigational biologics (other than
abatacept from previous or ongoing studies in Japan) at registration.

- Participants who have received treatment with any investigational drug within 56 days
before registration or five half-lives (whichever is the longest).

- Participants currently receiving treatment with leflunomide, mycophenolate mofetil,
calcineurine inhibitors such as cyclosporine and tacrolimus, D-Penicillamine,
Cyclophosphamide, or immunoadsorption columns.

- The participants who completed Phase II (IM101-071) are not applicable in the
following instances at time of registration: with active vasculitis, symptoms of
severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal,
pulmonary, cardiac, neurological, or cerebral disease, breast cancer, or a history of
cancer within the last 5 years, evidence of active or latent bacterial , viral
infections, any serious or chronic, at risk of tuberculosis (TB), with any
opportunistic infections, laboratory values of hemoglobin < 8.5 g/dL, white blood
cells (WBC) < 3,000/mm^3, Platelets < 100,000/mm^3, Serum creatinine > 2 times upper
limit of normal (ULN), Serum alanine transaminase or aspartate aminotransferase > 2
times ULN.



Age minimum: 20 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Primary Outcome(s)
Number of Participants With Abnormal Laboratory Changes (ALC) [Time Frame: From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).]
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs [Time Frame: From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).]
Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator [Time Frame: At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).]
Secondary Outcome(s)
Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State [Time Frame: Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.]
Abatacept PK Parameter: Maximum Serum Concentration at Steady State [Time Frame: Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.]
Abatacept PK Parameter: Minimum Plasma Concentration at Steady State [Time Frame: Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.]
Abatacept PK Parameter: Total Body Clearance [Time Frame: Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.]
Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28) [Time Frame: At BL (week 0), week 24, 48, 96, 144, and 192.]
Baseline and Postbaseline C-reactive Protein (CRP) Levels [Time Frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.]
Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores [Time Frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.]
Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores [Time Frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.]
Baseline and Postbaseline Rheumatoid Factor Levels [Time Frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.]
Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192 [Time Frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.]
Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 [Time Frame: At BL (Week 0), weeks 24, 48, 96, 144, and 192.]
Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192 [Time Frame: At baseline (week 0), weeks 24, 48, 96, 144, and 192.]
Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192 [Time Frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.]
Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192 [Time Frame: At weeks 24, 48, 96, 144, and 192.]
Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies [Time Frame: At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192.]
Number of Participants With DAS 28 Score Change = 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192 [Time Frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.]
Number of Participants With Low Disease Activity Score (DAS 28 Score = 3.2) at Weeks 24, 48, 96, 144, 192 [Time Frame: At weeks 24, 48, 96, 144, and 192.]
Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192 [Time Frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.]
Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192 [Time Frame: At BL (week 0), weeks 24, 48, 96, 144, and 192.]
Percentage of Participants With ACR 50 Response Over Time [Time Frame: At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.]
Percentage of Participants With ACR 70 Response Over Time [Time Frame: At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.]
Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time [Time Frame: At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.]
Secondary ID(s)
IM101-129
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 09/08/2012
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00484289
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