Rheumatoid Arthritis 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: Unless otherwise specified, to be eligible to participate in this study, 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 =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 of or=10 mm of induration [size of raised lump, not redness], or eq. positive tuberculosis (TB) test result as per country clinical standards) during the screening period. When PPD induration is >or=5 mm, but 38°C) or symptomatic viral infection or bacterial infection within 2W 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 and was without clinical abnormality) LAB. TESTS 13.Subjects with any laboratory test result at Screening considered clinically significant (as determined by Investigator) or o AST or ALT >1.5 times than ULN established by 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] at Screening TREATMENT HISTORY 15.Previous treatment with any anti-CD20 therapy (rituximab or ocrelizumab) or Campath (alemtuzumab) for the treatment of RA. 16.If subjects have previously received cell-depleting therapies (including, but not limited to, anti-CD3, anti-CD4, anti-CD5, anti-CD11a, anti-CD19, an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of BG9924 when administered in combination with MTX to subjects with active RA who have had an inadequate response to anti-TNF 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: •To assess the safety and tolerability of BG9924 in this patient population. •To assess the PK and PD profile of BG9924 in this patient population. ;Primary end point(s): The proportion of subjects with an ACR50 response at Week 14. | — |
Countries
Belgium, United Kingdom
Outcome results
None listed