Rheumatoid arthritis (RA) MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Sponsors
Biogen Idec Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Candidates must meet the following eligibility criteria at Day 0 (Visit 1/Week 0): 1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]). 2. Aged 18 to 75 years old, inclusive, at the time of informed consent. 3. Must have a diagnosis of adult onset RA according to the 1987 Revised American Rheumatism Association Criteria for the Classification of Rheumatoid Arthritis (Functional Class I–III) (Appendix A) for at least 6 months prior to Day 0. 4. Must have been treated with, and be tolerating, MTX (> or=10 mg/week to or =8 and a Tender Joint Count (TJC)> or =8 (66/68 joint count at Screening). 7. Must have elevated hsCRP > or =1.5 times the upper limit of normal (ULN) or ESR > or = 28 mm/hr at Screening. 8. Must be willing to receive oral folate (> or =5 mg/week) for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: MEDICAL HISTORY 1. Subjects with body weight or=10 mm of induration [size of raised lump, not redness], or equivalent positive tuberculosis (TB) test result as per country clinical standards) during the screening period. When the PPD induration is >or=5 mm, but 38°C) or symptomatic viral infection or bacterial infection within 2 weeks prior to D0 11.Receipt of live vaccine within 4W prior to D0 12.Clinically significant chest x-ray abnormality at Screening (Note: chest x-ray is not required if one was performed within 3 months of D0) LAB. TESTS 13.Subjects with any laboratory test result at Screening considered clinically significant (as determined by the Investigator) or o AST or ALT >1.5 times than ULN established by the central laboratory o Platelet count <150,000/µL o Hemoglobin <8.5 g/dL o Neutrophils <1.5 x 10exp3/µL 14.Positive for hepatitis C antibody or hepatitis B [HBsAg, HbcAb, or HBsAb] at Screening. Refer to full protocol for additional clarification. TREATMENT HISTORY 15.Previous treatment with anti-TNF therapy or any other non-TNF inhibitor biologic or prosorba column for the treatment of RA 16.If subjects have previously received cell-depleting therapies (incl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The proportion of subjects with an ACR50 response at Week 14 (Visit 8).;Main Objective: To evaluate the efficacy of 5 dose regimens of BG9924 when administered in combination with MTX to subjects with active RA who have had an inadequate response to conventional DMARD therapy. The primary efficacy outcome measure is the proportion of subjects with ACR50 at Week 14. To achieve ACR50 response, a 50% improvement compared to baseline is required for both swollen and tender joint counts, as well as 3 out of 5 additional parameters: subject’s global assessment of disease activity, Investigator’s global assessment of disease activity, subject’s assessment of pain, HAQ-DI, and hsCRP or ESR.; Secondary Objective: Secondary objectives of this study are as follows: - To assess the safety and tolerability of these 5 dose regimens of BG9924 in this patient population. - To assess the PK and PD profile of these 5 dose regimens of BG9924 in this patient population. | — |
Countries
Hungary, United Kingdom
Outcome results
None listed