Phase 2
Completed N=115
Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00554606 ↗Enrolled (actual)
115
Serious AEs
7.0%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants With Adverse Events and Serious Adverse Events — 91; 1; 8; 3 Participants
Summary
This study will assess the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events and Serious Adverse Events |
91; 1; 8; 3 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20) |
48.7; 49.6; 57.4; 53.3; 58.7; 54.2 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50) |
23.5; 23.5; 25.0; 30.8; 26.0; 32.3 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70) |
12.2; 11.3; 13.0; 13.1; 14.4; 16.7 | — |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90) |
2.6; 2.6; 2.8; 2.8; 1.9; 5.2 | — |
| SECONDARY Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI) |
11.3; 14.8; 16.7; 18.7; 19.2; 20.8 | — |
| SECONDARY Change From Baseline in ACR Component : Swollen Joint Count Through Week 54 |
6.0; 6.5; 5.8; 5.2; 5.0; 4.4 | — |
| SECONDARY Change From Baseline in ACR Component : Tender Joint Count Through Week 54 |
9.3; 9.5; 8.7; 7.9; 7.7; 7.1 | — |
| SECONDARY Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54 |
42.3; 41.2; 37.8; 37.1; 39.4; 36.8 | — |
| SECONDARY Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24 |
45.0; 44.1; 40.3; 39.9; 42.0; 38.3 | — |
| SECONDARY Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54 |
37.0; 38.7; 34.1; 33.0; 33.7; 27.8 | — |
| SECONDARY Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54 |
14.42; 15.30; 10.38; 10.10; 9.99; 8.35 | — |
| SECONDARY Core Study Change From Baseline in Edema, Erosion and Synovitis Score Was Assessed at Week 18 |
0; -0.043; 0; 0; -0.143; -0.714 | — |
| SECONDARY Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Erosion Score at Week 18 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Joint Narrowing Score at Week 18 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Core Study BMD of Total Lumbar Spine, Hip and Hand Was Assessed by DXA at Week 18 |
1.1650; 1.1760; 0.9000; 0.8570; 0.3295; 0.4280 | — |
| SECONDARY Number of Subjects With Long-term Immunogenicity |
108; 0; 1; 94; 0; 0 | — |
| SECONDARY Pharmacokinetic (PK) of ACZ885: Systemic Clearance From Serum Following Intravenous Administration (CL) in Participants |
0.210 | — |
| SECONDARY Pharmacokinetic (PK) of ACZ885: Volume Distribution From Serum Following Intravenous Administration (CL) in Participants |
3.34 | — |
| SECONDARY Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Physical Component) |
38.115; 39.374; 39.437; 38.264; 40.110; 38.295 | — |
| SECONDARY Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score |
1.107; 1.039; 0.981; 1.044; 1.061; 0.997 | — |
| SECONDARY Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Mental Component) |
44.947; 45.867; 44.701; 45.175; 49.993; 42.346 | — |
Eligibility Criteria
Inclusion Criteria
- Patients (male and non-pregnant, non-lactating females) who completed the core CACZ885A2204, CACZ885A2206, or CACZ885A2207 study without serious or severe drug-related adverse effects may enter the extension study upon signing informed consent
Exclusion Criteria
- Patients for whom continued treatment in the extension is not considered appropriate by the treating physician.
- Patients who were non-compliant or who demonstrated a major protocol violation in the core study.
- Patients who did not complete / discontinued from the core study.
- Patients with drug related serious adverse events or severe adverse events.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00554606). 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.