Phase 2
Completed N=78
Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00487825 ↗Enrolled (actual)
78
Serious AEs
3.9%
Results posted
May 2011
Primary outcomePrimary: Response to Intravenous Canakinumab and Oral Methotrexate (MTX) Compared to MTX Alone as Determined by 50% Improvement in Symptoms According to the American College of Rheumatology Criteria (ACR50) — 10; 5; 19; 9 Participants
Summary
This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response to Intravenous Canakinumab and Oral Methotrexate (MTX) Compared to MTX Alone as Determined by 50% Improvement in Symptoms According to the American College of Rheumatology Criteria (ACR50) |
10; 5; 19; 9; 24; 11 | — |
| SECONDARY Response to Intravenous (IV) Canakinumab and Oral Methotrexate (MTX) Therapy (ACR20, 70, 90) Compared to MTX Alone |
32; 13; 38; 16; 39; 20 | — |
| SECONDARY Percentage of Participants Achieving a Good European League Against Rheumatism (EULAR) Response (Based on the Disease Activity Score (DAS28)) at 26 Weeks |
46.2; 30.8; 28.8; 42.3; 17.3; 11.5 | — |
| SECONDARY The Number of Participants in Clinical Remission Based on Disease Activity Score (DAS)28 and Simplified Disease Activity Index (SDAI) |
6; 3; 13; 3; 20; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients of 18 to 75 years of age (inclusive)
- Recent definite diagnosis of rheumatoid arthritis (RA) ( 400 mL within 8 weeks before study start, or longer if required by local regulation.
- Significant illness within 2 weeks of study start.
- Past personal or family medical history of clinically significant ECG abnormalities or cardiac issues.
- History of:
- fainting, orthostatic hypotension, sinus arrhythmia asthma and chronic obstructive pulmonary disease, clinically significant drug allergy or urticaria, eczematous dermatitis, and/or known hypersensitivity to the study drug or drugs similar to the study drug.
- disease of the blood building system, serious or active infections, gastric ulcers.
- surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the patient in case of participation in the study.
- immunodeficiency diseases, including a positive Human Immunodeficiency Virus (HIV) (ELISA and Western blot) test result.
- positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse.
Data sourced from ClinicalTrials.gov (NCT00487825). 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.