Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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)

Key facts

Study ID

NCT00487825

Run by

Novartis

People needed

78

Starts

2007-03-01

Expected to finish

2008-12-01

Last updated by the study team

2012-08-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients of 18 to 75 years of age (inclusive)
• 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.

You may not qualify if…

• Unable to have Magnetic Resonance Imaging (MRI) of wrist.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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