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SB-681323 In Subjects With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00320450
First received: April 28, 2006
Last updated: May 31, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Arthritis, Rheumatoid
 Drug: SB-681323
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Parallel Group, Placebo-controlled, Double Blind Study to Assess the Safety and Tolerability of SB-681323 at 7.5mg Daily Dose for 28 Days and Its Effect on the Levels of Serum C-reactive Protein (CRP) in Subjects With Rheumatoid Arthritis (RA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. [ Time Frame: 28 Days ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 28 Days ]

Enrollment: 78
Study Start Date: November 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB-681323
    Other Name: SB-681323
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320450

  Show 36 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00320450     History of Changes
Other Study ID Numbers: RA1100849
Study First Received: April 28, 2006
Last Updated: May 31, 2012
Health Authority: Norway: Norwegian Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
SB-681323
CRP
Rheumatoid Arthritis SB-681323 CRP RA
Rheumatoid Arthritis
RA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013