Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose regimens of ACZ885, added on to stable methotrexate (MTX) therapy (greater than or equal to 7.5 mg/week), compared to placebo in patients with active rheumatoid arthritis (RA). The study investigated the magnitude of effect as well as onset of effect for the different dose regimens. The primary objective of the extension studies was to assess long-term safety and tolerability of canakinumab (ACZ885) in patients with active RA. CACZ885A2201E1 evaluated this objective in patients who had participated in the core study (CACZ885A2201) and CACZ885A2201E2 did the same in patients who completed the first extension study.

Key facts

Study ID

NCT00424346

Run by

Novartis

People needed

274

Starts

2006-11-01

Expected to finish

2009-10-01

Last updated by the study team

2014-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Core Study Inclusion Criteria At Screening
• Cooperative male or non-pregnant, non-lactating female patients at least 18 years of age who signed an informed consent before the initiation of any study procedure.
• Diagnosis of rheumatoid arthritis (RA) classified by American College of Rheumatology (ACR) 1987 revised criteria and with symptoms for at least 3 months before randomization.
• Functional status class I, II or III classified according to the ACR 1991 revised criteria.
• Patients treated with methotrexate (MTX) at the maximum tolerated (≤25 mg/week) and stable dose of ≥7.5 mg/week for at least 12 weeks before randomization.
• Patients who had failed any disease-modifying antirheumatic drugs (DMARDs) (including biologic agents and any DMARD used in combination with MTX) were allowed.
• For patients with previous treatment of biological therapy, the following wash-out periods were required before randomization:
• 3 days for Kineret™ (anakinra) - with a terminal half-life of 4 to 6 hours (s.c. route).
• 4 weeks for Enbrel® (etanercept) - with a terminal half-life of 102 ± 30 hours (s.c.
• route).
• 8 weeks for Remicade® (infliximab) - with a terminal half-life of 8.0-9. 5 days (intravenous (i.v.) infusion).
• 12 weeks for Humira® (adalimumab) - with a terminal half-life of 10-20 days (average 2 weeks) (subcutaneous (s.c.) route).
• 12 weeks for Orencia® (abatacept) - with a terminal half-life of 13.1 (8-25) days (i.v. infusion).
• 26 weeks for any other biologic - or 10 half-lives, whichever was longer.
• Patients who took systemic corticosteroids had to be on a stable dose of ≤10 mg/d prednisone or equivalent for at least 4 weeks before randomization.
• Patients who were regularly taking non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors or paracetamol/ acetaminophen as part of their RA therapy must have been on a stable dose for at least 4 weeks before randomization. Patients taking NSAIDs or COX-2 inhibitors or paracetamol/acetaminophen as needed within 2 weeks before randomization had to stop their medication at least 24 hours before an ACR visit (i.e. Visits 3, 7, 8, 10 and 12 [End of Study]). Patients taking folic acid supplementation had to be on stable dose for at least 4 weeks before randomization.
• Patients with a history of immunization for Influenza (within past 12 months) and Pneumococcal vaccination (within 4 years) were included. If not already immunized, vaccination was completed when medically indicated (only during flu season for influenza) and such patients were included after approximately a 3 week window post-immunization to allow immunity to develop for vaccine.
• Weight ≥45 kg and body mass index (BMI) <34.0
• Women of non-child-bearing potential, defined as all women physiologically not capable of becoming pregnant.
• Core Study Inclusion criteria At Baseline (Visit 3)
• Disease activity criteria of ≥6 out of 28 tender joints and ≥6 out of 28 swollen joints.
• One of the following also had to be present:
• High-sensitive C-Reactive Protein (hsCRP) concentration ≥10 mg/L
• Erythrocyte Sedimentation Rate (ESR) ≥28 mm/1st hr
• a. + b. based on screening values.

Where it is running

• Pinnacle Research Group — Anniston, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Sun Valley Arthritis Center, Ltd — Peoria, Arizona, United States
• Catalina Pointe Arthritis & Rheumatology Specialists — Tucson, Arizona, United States
• Arthritis Center — Palm Harbor, Florida, United States
• Arthritis Research of Florida, Inc. — Palm Harbor, Florida, United States
• The Arthritis Center — Springfield, Illinois, United States
• St. Louis Cener for Clinical Research — St Louis, Missouri, United States
• The Center for Rheumatology — Albany, New York, United States
• AAIR Research Center — Rochester, New York, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Tacoma Center for Arthritis Research — Tacoma, Washington, United States
• Novartis — Vienna, Austria
• Novartis — Vilvoorde, Belgium
• Novartis — Dorval, Quebec, Canada
• Novartis — Nuremberg, Germany
• Novartis — Barcelona, Spain

Full record on ClinicalTrials.gov

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