Phase IIIB Subcutaneous Abatacept Monotherapy Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00547521
• Date of registration: 19/10/2007
• Primary sponsor: Bristol-Myers Squibb
• Public title: Phase IIIB Subcutaneous Abatacept Monotherapy Study
• Scientific title: A Phase IIIb, Multi-center, Stratified, Open-Label Study to Evaluate the Immunogenicity, Steady State Trough Level, and Safety of Subcutaneous Abatacept (BMS-188667) in Subjects With Rheumatoid Arthritis Administered With or Without Background Methotrexate
• Date of first enrolment: December 2007
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00547521
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Australia, Brazil, Canada, Mexico, Peru, South Africa, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis of Rheumatoid Arthritis

- Subjects Global Disease Assessment of greater than equal to 20 mm on a visual analog
scale

- Discontinue all Biologics and Disease-modifying antirheumatic drugs (DMARDS) except
for methotrexate

Exclusion Criteria:

- Received treatment with rituximab

- Subjects who have received treatment with immunoadsorbtion columns (such as Prosorba
columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin
inhibitors, or D-Penicillamine



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis (RA)

Intervention(s)

Drug: abatacept

Drug: Methotrexate (MTX)

Primary Outcome(s)

Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for ELISA Results) [Time Frame: Baseline and on day 15, 29, 43, 57, 85 and 113]

Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for MSD Results) [Time Frame: Baseline and day 15, 29, 43, 57, 85 and 113.]

Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for ELISA Results) [Time Frame: Day 113.]

Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for MSD Results) [Time Frame: Day 113.]

Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study [Time Frame: Day 15, 29, 43, 57, 85,113 and 28, 56 and 85 days post last dose.]

Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study [Time Frame: Day 113]

Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study [Time Frame: Day 15, 29, 43, 57, 85,113 and 28, 56 and 85 days post last dose.]

Secondary Outcome(s)

Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study [Time Frame: Baseline and Month 4 (Day113).]

Change From Baseline in DAS28-CRP Score at End of 4-month (Day 113) of the ST Study [Time Frame: Baseline and Month 4 (Day113).]

Change From Baseline in Physical Functioning (HAQ-DI) at End of the 4-month Treatment Period (Day 113) of the ST Study [Time Frame: Baseline and Month 4 (Day 113).]

Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study [Time Frame: Baseline and Day 113.]

Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study [Time Frame: Days 1, 15, 29, 43, 57, 85 and 113.]

Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study [Time Frame: Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.]

Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study [Time Frame: Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.]

Number of Participants With AEs of Special Interest During the ST Study [Time Frame: Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.]

Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study [Time Frame: Day 113.]

Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study [Time Frame: Day 113.]

Number of Participants With Clinically Meaningful Improvement at End of 4-month (Day 113) of the ST Study [Time Frame: Day 113.]

Number of Participants With Clinically Meaningful Vital Signs During the ST Study [Time Frame: At screening and on days 1,15,29,43, 57, 85 and 113.]

Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes [Time Frame: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.]

Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) [Time Frame: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.]

Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN) [Time Frame: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.]

Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) [Time Frame: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.]

Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid [Time Frame: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.]

Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) [Time Frame: Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.]

Secondary ID(s)

IM101-173

Source(s) of Monetary Support

Please refer to primary and secondary sponsors