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SB-681323 In Subjects With Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00320450
First Posted: May 3, 2006
Last Update Posted: November 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320450


  Show 41 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00320450     History of Changes
Other Study ID Numbers: RA1100849
First Submitted: April 28, 2006
First Posted: May 3, 2006
Last Update Posted: November 4, 2013
Last Verified: May 2012

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