Safety Study of SCIO-469 to Treat Patients With Active Rheumatoid Arthritis Receiving Methotrexate

Scios, Inc.

Status and phase

Completed

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: SCIO-469

Study type

Interventional

Funder types

Industry

Identifiers

NCT00043732

CR005173

Details and patient eligibility

About

The main objective of the study is to evaluate the safety and tolerability of six escalating doses of SCIO-469 in RA patients. SCIO-469 belongs to a new class of treatments that inhibit p38 kinase, a stimulatory modulator of pro-inflammatory factors including tumor necrosis factor-alpha (TNF-alpha), interleukin-1 (IL-1), and cyclooxygenase-2 (COX-2), all of which are known to contribute to both symptoms and disease progression in patients with Rheumatoid Arthritis.

Full description

This multicenter, randomized, double-blind, placebo-controlled, dose-escalating study will assess the safety, tolerability, efficacy, PK and pharmacodynamics of SCIO-469 in patients with active RA who also are receiving methotrexate. A total of 120 subjects will be randomly assigned and treated in one of seven dose groups with the total daily dose of SCIO-469 ranging from 0 to 180 mg. Dose groups will be staggered over four Treatment Periods. Safety and available PK data from a Treatment Period with lower dose groups will be reviewed prior to initiating higher dose groups in the next Treatment Period. Placebo subjects will be randomized in all Treatment Periods. Study drug will be taken for 30 days. Each subject will be followed for approximately 4 weeks after completing the 30-day Treatment Period. Safety will be assessed by way of physical examination, medical history, vital signs, orthostatic vital signs, chest radiograph, 12-lead electrocardiogram (ECG), clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests), purified protein derivative test for tuberculosis, neurological tests, adverse events, and concomitant medications through out the study. Study drug will be administered for 30 days at one of the following dosage strengths; 30 mg, 60 mg, 90 mg. One group of subjects will get 60 mg for one week followed by 120 for one week followed by 180 mg for two weeks.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who have active rheumatoid arthritis and are receiving methotrexate
meet the revised 1987 American Rheumatism Association (ARA) criteria for rheumatoid arthritis
has active RA as demonstrated by 9 tender and 6 swollen joints and one of the following: C-reactive protein 1.0 mg/dL, Erythrocyte sedimentation rate (ESR) 28 mm/hour, or Morning stiffness = 45 minutes. .

Exclusion criteria

Patient used etanercept, infliximab, anakinra, or an experimental biologic agent within past 3 months
Had elevation of liver enzymes within past 6 months
Has a history of Tuberculosis
Vertigo, inner ear, or vestibular abnormalities
Cancer
HIV-positive
Abnormal electrocardiogram
patient has chronic or acute infection
Multiple sclerosis, neuropathy or encephalopathy