SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate

Scios, Inc.302 enrolled

Overview

The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs).

This is a 24 week randomized (study drug assigned by chance), double blind (neither physician nor patient knows the name of the assigned drug), placebo controlled, parallel group study assessing the safety and effectiveness of oral SCIO-469 in treating patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs). The patient will participate in the study for approximately 183 days. Safety measures will include vital signs (blood pressure, pulse rate, breathing rate), 12-lead electro-cardiogram, adverse events, concomitant medications, and clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests). The patient may be assigned to receive 30 mg capsule orally (by mouth) as one or two capsules three times daily, or receive 100 mg tablet orally once daily, or placebo (no active drug) orally as two capsules three times daily and placebo tablet orally once daily for 24 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

302

Conditions

Arthritis, Rheumatoid

Interventions

SCIO-469DRUG

60 mg capsule three times daily for 12 weeks

SCIO-469DRUG

30 mg capsule three times daily for 12 weeks

PlaceboDRUG

2 capsules three times daily and one tablet daily

SCIO-469

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients having active rheumatoid arthritis who are not receiving medications known as hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs) * Patients taking hydroxychloroquine (Plaquenil) must be on a stable or consistent dose prior to entering study Exclusion Criteria: * Patients using Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months * Lab tests revealed elevated liver enzymes within the past 6 months * Medical history of Tuberculosis, cancer, multiple sclerosis, neuropathy or encephalopathy * HIV positive * Abnormal electrocardiogram * Chronic or acute infection

Outcomes

Primary Outcomes

ACR20 is 20% reduction in tender and swollen joint counts and 20% improvement in three of the five remaining ACR core set measures: patient and physician global assessments, visual analog scale for pain, HAQ, and an acute-phase reactant (CRP or ESR)

Time frame: Day 1 to approximately Day 85 of treatment

Secondary Outcomes

ACR50 responders at Week 12

Time frame: 12 weeks

ACR20 and ACR50 responders at each evaluation visit other than Week 12

Time frame: 24 weeks

All individual variables of the ACR response criteria at each evaluation visit

Time frame: 24 weeks

Disease Activity Score (DAS)28 at each evaluation visit.

Time frame: 24 Weeks

The number of participants experiencing adverse events (AEs) as a measure of safety

Time frame: 24 weeks

Data from ClinicalTrials.gov

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