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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
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.
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) was supplied in tablet form, each of 2.5 mg strength.
Rheumatology Associates of Northern Alabama (Dr. William Shergy)
Response to Intravenous Canakinumab and Oral Methotrexate (MTX) Compared to MTX Alone as Determined by 50% Improvement in Symptoms According to the American College of Rheumatology Criteria (ACR50)
A patient was considered as improved according to the ACR50 criteria if she/he had at least a 50 % improvement in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: * Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm) * Patient's global assessment of disease activity (VAS 100 mm) * Physician's global assessment of disease activity (VAS 100 mm) * Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score) * Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))
Time frame: 6, 14, and 26 weeks of treatment
Response to Intravenous (IV) Canakinumab and Oral Methotrexate (MTX) Therapy (ACR20, 70, 90) Compared to MTX Alone
A patient was considered as improved according to the criteria of ACR 20 equaling at least 20%, ACR70 = 70%, and ACR90 = 90% improvement in the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: * Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm) * Patient's global assessment of disease activity (VAS 100 mm) * Physician's global assessment of disease activity (VAS 100 mm) * Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score) * Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))
Time frame: At 6 weeks, 14 weeks, and 26 weeks
Percentage of Participants Achieving a Good European League Against Rheumatism (EULAR) Response (Based on the Disease Activity Score (DAS28)) at 26 Weeks
At each visit (including baseline) the DAS28 is derived as: DAS28 = 0.56\*√ (tender28) + 0.28 \* √ (swollen28) + 0.36 \* loge(CRP+1) + 0.014\*PGDA+ 0.96; where tender28 is the tender 28-joint count, swollen28 is the swollen 28-joint count, PGDA is the patient's global assessment of disease activity. Patients can be scored on a range of 0 to 10. When current DAS \< 3.2, good response is defined as \>1.2 improvement in DAS from baseline and non-response is improvement of ≤0.6. When current DAS \>5.1, non-response is improvement of \>0.6 but ≤1.2 . All others are moderate responses.
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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
...and 12 more locations
Time frame: At 26 weeks
The Number of Participants in Clinical Remission Based on Disease Activity Score (DAS)28 and Simplified Disease Activity Index (SDAI)
At each visit (including baseline) the DAS28 and SDAI variables were derived using the following formulas: DAS28 = 0.56\*√ (tender28) + 0.28 \* √ (swollen28) + 0.36 \* loge(CRP+1) + 0.014\*PGDA+ 0.96; SDAI = tender28 + swollen28 + CRP + (PGDA / 10) + (EGDA / 10) where tender28 is the tender 28-joint count, swollen28 is the swollen 28-joint count, CRP is C-reactive protein, PGDA is the patient's global assessment of disease activity and EGDA is the physician's global assessment of disease activity. The Number of Participants in clinical remission is defined as the DAS28 ≤ 2.6 or SDAI ≤ 3.3.
Time frame: At 6 weeks, 14 weeks and 24 weeks