safety and efficacy of intravenous acz885 and oral methotrexate therapy in patients with early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

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)


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.

Keywords: acr20, acr50, acz885 (anti-interleukin-1beta monoclonal antibody), rheumatoid arthritis, methotrexate