A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapy
- Conditions
- Rheumatoid ArthritisMedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis
- Registration Number
- EUCTR2006-005467-26-GB
- Lead Sponsor
- Biogen Idec Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 5.Must have had an inadequate response to anti-TNF therapy (etanercept, infliximab, or adalimumab) due to inadequate efficacy or toxicity.
6.Must have a Swollen Joint Count (SJC) >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
MEDICAL HISTORY
1.Subjects with body weight of <50kg
2.Subjects with history of malignancy or carcinoma in situ (subjects with a history of excised or treated basal cell carcinoma are eligible to participate in this study)
3.Subjects with mole or lesion currently undiagnosed, but suspicious for malignancy. Any suspicious skin lesion should be evaluated and excised by a dermatologist prior to inclusion in the study
4.History of clinically significant (as determined by Investigator) cardiac, allergic, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal or hematologic insufficiency, or any major disease that could affect any of the efficacy assessments, in particular, joint pain and swelling (e.g. Parkinsons disease, cerebral palsy, diabetic neuropathy)
5.Subjects with rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome). Secondary Sjogren's syndrome or secondary limited cutaneous vasculitis within RA is permitted
6.Serious local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) within 3 months prior to D0 (V1/W0)
7.History of recurrent infections requiring oral or parental anti-infective drug treatment
8.Primary or secondary immunodeficiency (history of or currently active) including known history of HIV infection
9.History of tuberculosis or positive purified protein derivative (PPD; positive Mantoux test defined as >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 <10 mm the subject is eligible for the study if they have had a negative chest x-ray during screening period. There must be no other clinical evidence of TB on physical examination of the subject. Note: Subjects who have had prior adequate prophylaxis treatment for latent TB with an appropriate course of isoniazid (INH) or equivalent, per country standards, are not excluded from study participation.
10.Fever (body temp. >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method