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

NCT ID: NCT00089921

Last Updated: 2010-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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001

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

Group Type EXPERIMENTAL

SCIO-469

Intervention Type DRUG

30 mg capsule three times daily for 12 weeks

002

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

Group Type EXPERIMENTAL

SCIO-469

Intervention Type DRUG

60 mg capsule three times daily for 12 weeks

003

SCIO-469 100 mg tablet once daily for 12 weeks

Group Type EXPERIMENTAL

SCIO-469

Intervention Type DRUG

100 mg tablet once daily for 12 weeks

004

Placebo 2 capsules three times daily and one tablet daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 capsules three times daily and one tablet daily

Interventions

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SCIO-469

100 mg tablet once daily for 12 weeks

Intervention Type DRUG

SCIO-469

60 mg capsule three times daily for 12 weeks

Intervention Type DRUG

SCIO-469

30 mg capsule three times daily for 12 weeks

Intervention Type DRUG

Placebo

2 capsules three times daily and one tablet daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scios, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Centocor Research & Development, Inc., PA, USA

Principal Investigators

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Scios, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Scios, Inc.

Other Identifiers

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SCIO-469ARA2003

Identifier Type: -

Identifier Source: secondary_id

B007

Identifier Type: -

Identifier Source: secondary_id

CR005167

Identifier Type: -

Identifier Source: org_study_id