A phase 2b, randomised, double-blind, placebo-controlled, multi-centre, dose-finding 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

Biogen Idec Ltd0 sites120 target enrollmentFebruary 14, 2007

ConditionsRheumatoid arthritis (RA)MedDRA version: 9.1Level: PTClassification code 10039073Term: Rheumatoid arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid arthritis (RA)
Sponsor: Biogen Idec Ltd
Enrollment: 120
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 14, 2007

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Biogen Idec Ltd

Eligibility 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 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

Exclusion Criteria

•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.