SB-681323 In Subjects With Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Arthritis, Rheumatoid

• Registration Number: NCT00320450
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this research is to find out how effective and safe SB-681323 will be in the treatment of RA when it is added to standard anti-rheumatic treatments.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-04-28
• Study First Submitted QC: 2006-04-28
• Study First Posted: 2006-05-03
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2012-05
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Females cannot be pregnant or lactating.
• Must use defined contraceptive methods if of child-bearing potential.
• BMI range: 18.5-35.0 kg/m2.
• Diagnosis of RA (rheumatoid arthritis) according to revised 1987 American College of Rheumatology (ACR) criteria.
• If other RA-medication is used: Disease-Modifying Anti-Rheumatic Drug (DMARDS) must be stable for at least 8 weeks before first trial visit.
• If other oral anti-RA therapies are used, these must have been stable at least 4 weeks before first trial visit.
• If Methotrexate medication is used as RA-therapy, Folate supplement must be taken with stable red cell folate levels.
• Must give informed consent.
• Must abstain from alcohol during the trial participation.

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Exclusion Criteria

• Non-responder on biological RA treatment.
• Has a positive alcohol screen.
• Any history of liver disease.
• Positive Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of screening.
• Have any significant disease that places the subject at unacceptable risk as a participant in this trial.
• Acute infection.
• History of active tuberculosis.
• History of repeated or chronic infection.
• History of malignancy.
• History of HIV or other immunosuppressive diseases.
• Participated in a clinical trial within the last 3 months for non-biological therapies and 6 months for biological therapies.
• Uncontrolled diabetes or psoriasis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum levels of CRP at the end of study (after 28 days of treatment) following repeat dosing with SB-681323 (7.5mg/day) compared with placebo.	28 Days

Secondary Outcome Measures

Name	Time	Method
Serum levels of CRP at other available timepoints. The following secondary endpoints will be analysed at all available timepoints: Clinical Symptoms, Safety and Biomarkers, Health Outcome.	28 Days

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Sheffield, United Kingdom