Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis
NCT ID: NCT00487825
Last Updated: 2012-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2007-03-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Canakinumab + Methotrexate
Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. MTX was given as variable dosing regimen of 7.5 mg-15 mg weekly.
Canakinumab (investigational)
Canakinumab was supplied in 6 mL colorless glass vials each containing nominally 150 mg canakinumab (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
Methotrexate (MTX)
Methotrexate (MTX) was supplied in tablet form, each of 2.5 mg strength.
Methotrexate + placebo
Methotrexate (MTX) was given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
Placebo
Matching placebo was supplied in form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
Methotrexate (MTX)
Methotrexate (MTX) was supplied in tablet form, each of 2.5 mg strength.
Interventions
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Canakinumab (investigational)
Canakinumab was supplied in 6 mL colorless glass vials each containing nominally 150 mg canakinumab (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
Placebo
Matching placebo was supplied in form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
Methotrexate (MTX)
Methotrexate (MTX) was supplied in tablet form, each of 2.5 mg strength.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Recent definite diagnosis of rheumatoid arthritis (RA) (\<3 years since diagnosis), classified by American Rheumatism Association 1987 revised criteria.
* Candidate for methotrexate (MTX) or biologic due to erosive arthritis, with no contraindications to such therapy, including:
* Negative tuberculin skin test reaction
* Normal chest X-ray (within the last year) prior to possibility of receiving MTX (r/o lung fibrosis).
* Active disease: at least 6 swollen and 6 painful tender joints of 28 joint count,
* Vital signs should be within the following ranges:
* 18-59 years of age: oral temperature between 35.0-37.5 °C systolic blood pressure, 90-140 mm Hg diastolic blood pressure, 50-90 mm Hg pulse rate, 40 - 90 beats per minute
* 60-75 years of age: oral temperature between 35.0-37.5 °C systolic blood pressure, 100-160 mm Hg diastolic blood pressure, 50-100 mm Hg pulse rate, 50 - 100 beats per minute
* Women of child-bearing potential willing to practice double-barrier contraception during the study for at least 3 months following last study drug administration. Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion. Surgically sterilized women at least 6 months prior to screening.
Male patients must be using a double-barrier local contraception and refrain from fathering a child in the 3 months following last study drug administration.
* Weight: at least 45 kg; body mass index (BMI) within the range of 18 to 34.
* Oral corticosteroids are permitted as long as patients are on a stable dose (up to 10 mg) for at least 4 weeks before study start.
Exclusion Criteria
* Patients with magnetizable metal parts/devices on and in the body that could interfere with the MRI
* Patients with an unstable active medical condition that could impair evaluation of study results.
* Previous treatment with biological therapy or MTX.
* Limited kidney function (creatinine clearance under 60 ml/min)
* Previous treatment with other disease-modifying anti-rheumatic drugs such as sulfasalazine, hydroxychloroquine within 4 weeks of screening.
* Corticosteroids injections into joints within 4 weeks prior to screening.
* Participation in any clinical investigation within 4 weeks prior to study start or longer if required by local regulations, and for any other limitation of participation based on local regulations.
* Blood donation or loss of \> 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.
18 Years
75 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis
Role: PRINCIPAL_INVESTIGATOR
Investigative site
Locations
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Rheumatology Associates of Northern Alabama (Dr. William Shergy)
Huntsville, Alabama, United States
Clinic for Rheumatic Diseases (Dr. Richard Jones, III)
Tuscaloosa, Alabama, United States
Arizona Arthritis and Rheumatology Research (Dr. Paul Caldron)
Paradise Valley, Arizona, United States
Jacksonville Center for Clinical Research (Dr. Steven Mathews)
Jacksonville, Florida, United States
Center for Arthritis and Rheumatic Diseases (Dr. Michael Weitz)
South Miami, Florida, United States
West Broward Rheumatology Associates, Incorporated (Dr. Elias Halpert)
Tamarac, Florida, United States
Rockford Orthopedic Associates (Dr. Richard Olson)
Rockford, Illinois, United States
Mercy Arthritis and Osteoporosis Center (Dr. Alan Braun)
Urbandale, Iowa, United States
Clayton Medical Research (Dr. Iri Don)
Richmond Heights, Missouri, United States
Westroads Medical Group (Dr. William Palmer)
Omaha, Nebraska, United States
Arthritis Center of Reno (Dr. Malin Prupas)
Reno, Nevada, United States
Oklahoma Center for Arthritis therapy and Research (Dr. James McKay)
Tulsa, Oklahoma, United States
MetaClin Research, Incorporated (Dr. Paul Pickrell)
Austin, Texas, United States
John M. Joseph, MD (Dr. John Joseph)
Carlton, Texas, United States
Southwest Rheumatology, P.A. (Dr. Atul Singhal)
Mesquite, Texas, United States
Arthritis Clinic of Northern Virginia (Dr. Philip Kempf)
Arlington, Virginia, United States
Arthritis Northwest Rheumatology, PLLC (Dr. Jeffrey Butler)
Spokane, Washington, United States
Novartis Investigative site
Brussels, , Belgium
Novartis investigative site
Nuremberg, , Germany
Novartis investigative site
Milan, , Italy
Novartis Investigative site
Arnhem, , Netherlands
Novartis investigative site
Barcelona, , Spain
Countries
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Other Identifiers
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CACZ885A2204
Identifier Type: -
Identifier Source: org_study_id