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

Scios, Inc.

Status and phase: Completed; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Placebo; Drug: SCIO-469

Study type: Interventional

Funder types: Industry

Identifiers

NCT00089921

B007

SCIO-469ARA2003

CR005167

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

302 participants in 4 patient groups, including a placebo group

001

Experimental group

Description:

SCIO-469 30 mg capsule three times daily for 12 weeks

Treatment:

Drug: SCIO-469

Drug: SCIO-469

Drug: SCIO-469

002

Experimental group

Description:

SCIO-469 60 mg capsule three times daily for 12 weeks

Treatment:

Drug: SCIO-469

Drug: SCIO-469

Drug: SCIO-469

003

Experimental group

Description:

SCIO-469 100 mg tablet once daily for 12 weeks

Treatment:

Drug: SCIO-469

Drug: SCIO-469

Drug: SCIO-469

004

Placebo Comparator group

Description:

Placebo 2 capsules three times daily and one tablet daily

Treatment:

Drug: Placebo