A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate - F2201

ovartis Pharma Services AG0 sites200 target enrollmentSeptember 9, 2009

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: ovartis Pharma Services AG
Enrollment: 200
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 9, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma Services AG

Eligibility Criteria

Inclusion Criteria

•? Male or non\-pregnant, non\-lactating females at least 18 years of age.
•? Presence of RA classified by ACR 1987 revised criteria. Patients with active RA must currently be treated with a stable dose of MTX (\=7\.5 mg/week \- \=25 mg/week) for at least 4 weeks. The should have been traeted with MTX for at lest 3 months.
•? At Baseline: Disease activity criteria defined by \=6 out of 28 tender joints and \=6 out of 28 swollen joints. WITH either a.Screening value of hsCRP \= 10 mg/L b.OR ESR \=28 mm/1st hr
•? Patients who failed any DMARD including biologic DMARDs and any DMARDs used in combination with MTX will be allowed entry into study after appropriate wash\-out period (except for MTX) prior to baseline:
•28 days for DMARDs , except for leflunomide, which has to be discontinued for 8 weeks prior to baseline unless a cholestyramine washout has been performed.
•7 days for Kineret – with a terminal half\-life of 4 to 6 hours (s.c. route).
•4 weeks for Enbrel – with a terminal half\-life of 102 ± 30 hours (s.c. route).
•8 weeks or longer for Remicade – with a terminal half\-life of 8\.0\-9\.5 days (i.v. infusion).
•12 weeks for Humira – with a terminal half\-life of 10\-20 days (average 2 weeks) (s.c. route).
•12 weeks for Orencia – with a terminal half\-life of 13\.1 (8\-25\) days (i.v. infusion).

Exclusion Criteria

•? RA patients functional status class IV classified according to the ACR 1991 revised criteria
•? Patients taking high potency opiod analgesics (e.g., methadone, hydromorphone, or morphine)
•? Any therapy by i.a. (e.g. steroids) required for treatment of acute RA flare within 4 weeks before randomization.
•? Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL)
•? WCBP, defined as all women physiologically capable of becoming pregnant, UNLESS using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some IUDs, Periodic abstinence (e.g. calendar, ovulation, symptothermal, post\-ovulation methods) are not acceptable
•? Males who do not consent to practice contraception during study (for details see protocol).
•? Inflammatory diseases other than RA that might confound the evaluation of the benefit of AIN457, thus other rheumatic diseases that could confound the evaluation of efficacy, including but not limited to primary fibromyalgia, ankylosing spondylitis, Lyme disease, adult JRA,SLE, gout and pseudo gout, vasculitis, PsA, reactive arthritis, primary Sjoegren’s, and Behcet’s.
•? Underlying metabolic, hematologic, pulmonary, neurologic, encocrine renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in an immunodulatory therapy. In particular, clinical evidence or history of Felty’s syndrome.
•? With significant medical problems, including but not limited to the following: uncontrolled hypertension (\=160/95 mmHg), congestive heart failure \[NYHA III or IV ].
•? Active systemic infections during the last two weeks (exception: common cold) prior to randomisation.