Phase 3
Completed N=100
Phase IIIB Subcutaneous Abatacept Monotherapy Study
Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT00547521 ↗
Enrolled (actual)
100
Serious AEs
20.5%
Results posted
Jan 2011
Primary outcomePrimary: Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study — 0; 0 participants
Summary
To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study |
0; 0 | — |
| PRIMARY Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study |
0; 0; 2; 0; 2; 0 | — |
| PRIMARY Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study |
1; 1; 1; 0; 1; 0 | — |
| PRIMARY Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for ELISA Results) |
— | — |
| PRIMARY Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for MSD Results) |
— | — |
| PRIMARY 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) |
— | — |
| PRIMARY 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) |
— | — |
| SECONDARY Change From Baseline in DAS28-CRP Score at End of 4-month (Day 113) of the ST Study |
-1.67; -1.94 | — |
| SECONDARY Number of Participants With Clinically Meaningful Improvement at End of 4-month (Day 113) of the ST Study |
30; 30 | — |
| SECONDARY Change From Baseline in Physical Functioning (HAQ-DI) at End of the 4-month Treatment Period (Day 113) of the ST Study |
-0.31; -0.58 | — |
| SECONDARY Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study |
-0.44; -0.57; -0.26; -0.59; -0.28; -0.57 | — |
| SECONDARY Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study |
12; 15; 2; 0; 1; 1 | — |
| SECONDARY Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study |
0; 0; 2; 3; 37; 32 | — |
| SECONDARY Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study |
14; 12; 1; 1 | — |
| SECONDARY Number of Participants With AEs of Special Interest During the ST Study |
18; 14; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) |
0; 0; 3; 3; 0; 0 | — |
| SECONDARY 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) |
0; 0; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY 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) |
0; 2; 1; 0; 1; 3 | — |
| SECONDARY Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study |
36; 32; 11; 12 | — |
| SECONDARY Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study |
41; 37; 4; 8 | — |
| SECONDARY Number of Participants With Clinically Meaningful Vital Signs During the ST Study |
0; 0 | — |
| SECONDARY Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study |
13.69; 11.23; 19.39; 15.64; 23.40; 18.06 | — |
| SECONDARY Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study |
0; 1; 0; 0; 2; 0 | — |
| SECONDARY Change From Baseline in DAS28-CRP Score in the LTE Study - All Treated Participants in LTE Study |
-1.89; -2.39 | — |
| SECONDARY Number of Participants With Clinically Meaningful Improvement From Baseline in the LTE Study - All Treated Participants in LTE Study |
59; 43 | — |
| SECONDARY Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE |
28; 28; 45; 37 | — |
| SECONDARY Change From Baseline in HAQ-DI in the LTE Study - All Treated Participants in LTE Study |
-0.47; -0.56 | — |
| SECONDARY Number of Participants With HAQ Responses in the LTE Study - All Treated Participants in the LTE STudy |
53; 41 | — |
| SECONDARY Number of Participants With Negative Status for RF up to 7 Days After Last Dose of Abatacept in the LTE Period - All Treated Participants in LTE Study |
20 | — |
| SECONDARY Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup |
-2.42; -2.58; -0.60; -0.65 | — |
| SECONDARY Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup |
14; 9; 18; 13 | — |
| SECONDARY Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study |
0; 34; 6; 3; 86; 34 | — |
| SECONDARY Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study |
69; 5; 4; 2; 12 | — |
| SECONDARY Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study |
1; 0; 0; 0; 0; 2 | — |
| SECONDARY Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study |
0; 1; 3; 2; 0; 6 | — |
| SECONDARY Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study |
0; 2; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study |
6; 2; 13; 12; 26; 16 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00547521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.