Phase 3
Completed N=50
A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00420199 ↗
Enrolled (actual)
50
Serious AEs
4.0%
Results posted
May 2011
Primary outcomePrimary: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) — 4.48; 3.52 units on a scale
Summary
The only trial in participants who are methotrexate-inadequate responders and have active Rheumatoid Arthritis, in which gadolinium-enhanced Magnetic Resonance Imaging; Bone Mineral Density; and biochemical markers of bone, cartilage, and synovial tissue metabolism are used to evaluate early effects (4 months) of Abatacept on inflammation/structural damage. Study will provide valuable mechanism-of-action information on how Abatacept exerts its effects (including on bone) through new techniques.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) |
4.48; 3.52 | — |
| PRIMARY Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA |
-0.44; 0.52 | 0.103 |
| PRIMARY Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis |
-0.31; 0.38 | 0.078 |
| SECONDARY Double-blind Period: Baseline Mean Erosion OMERACT 6 Scores |
12.60; 9.65 | — |
| SECONDARY Double-blind Period: Adjusted Mean Change From Baseline in Erosion OMERACT 6 Scores |
0.45; 0.95 | — |
| SECONDARY Double-blind Period: Baseline Mean Osteitis OMERACT 6 Scores |
7.72; 8.00 | — |
| SECONDARY Double-blind Period: Adjusted Mean Change From Baseline in Osteitis OMERACT 6 Scores |
-1.94; 1.54 | — |
| SECONDARY Double-blind Period: Number of Participants With Newly Involved Joints in Bone Erosion, Edema/Osteitis, and Synovitis |
20; 16; 5; 7; 18; 16 | — |
| SECONDARY Double-blind Period: Baseline Mean RAMRIS Scores |
24.80; 21.17 | — |
| SECONDARY Double-blind Period: Adjusted Mean Change From Baseline in RAMRIS Scores |
-1.82; 2.89 | — |
| SECONDARY Double-blind Period: Median Percent Change From Baseline in Systemic Markers of Bone Formation: Osteocalcin and Serum Intact N-terminal Propeptide of Type I Procollagen (PINP) |
1.82; 4.41; 6.83; 3.94; 2.43; 12.14 | — |
| SECONDARY Double-blind Period: Median Percent Change From Baseline in Systemic Markers of Bone Destruction (Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen [CTX-I] and Serum Pyridinoline Cross-linked Telopeptide Domain of Type I Collagen [ICTP]) |
1.65; -6.37; -5.56; 6.25; 0.48; -0.72 | — |
| SECONDARY Double-blind Period: Median Percent Change From Baseline in a Systemic Marker of Cartilage Degradation (Creatinine-corrected Urinary Carboxyterminal Crosslinking Telopeptide of Type II Collagen [UCTX2C]) |
-8.51; 5.14; -3.40; 6.81; 0.24; 5.43 | — |
| SECONDARY Double-blind Period: Median Percent Change From Baseline in Systemic Marker of Synovial Tissue Metabolism (Creatinine-corrected Urinary Glucosyl-Galactosyl-Pyridinoline [UGGPC]) |
4.44; -3.84; -1.83; -3.19; 1.58; 5.73 | — |
| SECONDARY Double-blind Period: Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation |
0; 0; 0; 2; 0; 0 | — |
| SECONDARY Double-blind Period: Number of Participants With AEs of Special Interest |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Double-blind Period: Number of Participants With Infections/Infestations of Special Interest |
1; 0 | — |
| SECONDARY Double-blind Period: Number of Participants With Acute Infusional AEs of Special Interest |
0; 1; 0; 1; 0; 1 | — |
| SECONDARY Double-blind Period: Number of Participants With Peri-infusional AEs of Special Interest |
3; 0; 0; 1; 1; 1 | — |
| SECONDARY Double-blind Period: Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality |
0; 1; 0; 1; 0; 0 | — |
| SECONDARY Double-blind Period: Number of Participants With Laboratory Test Results for Liver and Kidney Function Meeting Criteria for Marked Abnormality |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Double-blind Period: Number of Participants With Laboratory Test Results for Electrolytes Meeting the Criteria for Marked Abnormality |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Double-blind Period: Number of Participants With Laboratory Test Results in Other Chemistries and Urinalysis Meeting the Criteria for Marked Abnormality |
1; 0; 1; 1; 0; 0 | — |
| SECONDARY Double-blind Period:Number of Participants With Significantly Abnormal Changes in Vital Signs |
0; 0 | — |
| SECONDARY Double-blind Period: Number of Participants With Positive Antibodies to Abatacept by Electrochemiluminescence (ECL) Assay |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Disease activity as defined by a Disease Activity Score 28-C-Reactive Protein (CRP) >3.2 or >6 swollen and ≥6 tender joints and CRP greater than the upper limit of normal
- At least 1 erosion in hands/wrists or positive anticyclic citrullinated peptides or rheumatoid factor
- Clinically detectable synovitis of at least 1 wrist/ankle at screening and baseline
- Participants must have been treated with methotrexate, on a weekly dose of at least 15 mg or a maximum tolerated dose (such as, 10 mg weekly) for at least 3 months before screening. Dose of methotrexate must be stable for at least 28 days prior to the first study dose (Day 1)
Data sourced from ClinicalTrials.gov (NCT00420199). 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.