Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00424346
First received: January 17, 2007
Last updated: May 27, 2009
Last verified: May 2009
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Purpose
This 12-week study is 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 will investigate the magnitude of effect as well as onset of effect for the different dose regimens.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: ACZ885 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-Interleukin-1beta Monoclonal Antibody) With Three Different Dose Regimens in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Response to treatment (American College of Rheumatology [ACR]50 criteria), of three dose regimens of ACZ885 compared to placebo as add-on treatment to MTX [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response to treatment (ACR20 and ACR70 criteria, Disease Activity Score [DAS]28) assessment [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
- Onset of effect assessment based on ACR20 and ACR50 [ Time Frame: at 2, 4 and 8 weeks ] [ Designated as safety issue: No ]
- Assessment of effect on ACR components, including marker of inflammation (hsCRP) [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
- Immunogenicity assessment after repeat exposure [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 273 |
| Study Start Date: | November 2006 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: ACZ885 |
| Experimental: 2 | Drug: ACZ885 |
| Experimental: 3 | Drug: ACZ885 |
| Placebo Comparator: 4 | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Other protocol-defined inclusion/exclusion criteria may apply
Inclusion criteria
- Male or non-pregnant, non-lactating female patients at least 18 years of age
- Patients treated with MTX at the maximum tolerated (< or equal to 25 mg/week) and stable dose of > or equal to 7.5 mg/week for at least 12 weeks before randomization
- Patients who failed any Disease Modifying Antirheumatic Drug (DMARDs) (incl. biologic agents and any DMARD used in combination with MTX) will be allowed
Exclusion criteria
- Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment of acute RA flare within 4 weeks
- Evidence of active pulmonary disease (e.g. tuberculosis, fungal diseases)
- History of a positive purified protein derivative (PPD) of tuberculin skin test without a follow-up of a negative chest X-ray
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424346
Locations
| United States, Alabama | |
| Pinnacle Research Group | |
| Anniston, Alabama, United States, 36207 | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Sun Valley Arthritis Center, Ltd | |
| Peoria, Arizona, United States, 85381 | |
| Catalina Pointe Arthritis & Rheumatology Specialists | |
| Tucson, Arizona, United States, 85704 | |
| United States, Florida | |
| Arthritis Research of Florida, Inc. | |
| Palm Harbor, Florida, United States, 34684 | |
| Arthritis Center | |
| Palm Harbor, Florida, United States, 34684 | |
| United States, Illinois | |
| The Arthritis Center | |
| Springfield, Illinois, United States, 62704 | |
| United States, Missouri | |
| St. Louis Cener for Clinical Research | |
| St. Louis, Missouri, United States, 63128 | |
| United States, New York | |
| The Center for Rheumatology | |
| Albany, New York, United States, 12206 | |
| AAIR Research Center | |
| Rochester, New York, United States, 14618 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97239 | |
| United States, Washington | |
| Tacoma Center for Arthritis Research | |
| Tacoma, Washington, United States, 98405 | |
| Austria | |
| Novartis | |
| Vienna, Austria | |
| Belgium | |
| Novartis | |
| Vilvoorde, Belgium | |
| Canada, Quebec | |
| Novartis | |
| Dorval, Quebec, Canada | |
| Germany | |
| Novartis | |
| Nuernberg, Germany | |
| Spain | |
| Novartis | |
| Barcelona, Spain | |
Sponsors and Collaborators
Novartis
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | External Affairs, Novartis |
| ClinicalTrials.gov Identifier: | NCT00424346 History of Changes |
| Obsolete Identifiers: | NCT00471198, NCT00784628 |
| Other Study ID Numbers: | CACZ885A2201 |
| Study First Received: | January 17, 2007 |
| Last Updated: | May 27, 2009 |
| Health Authority: | United States: Food and Drug Administration Austria: Federal Ministry for Health and Women Belgium: Directorate general for the protection of Public health: Medicines Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Spain: Spanish Agency of Medicines |
Keywords provided by Novartis:
|
Active Rheumatoid Arthritis anti-interleukin-1beta monoclonal antibody methotrexate |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Antibodies, Monoclonal Methotrexate Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Abortifacient Agents, Nonsteroidal |
Abortifacient Agents Reproductive Control Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013