SB-681323 In Subjects With Rheumatoid Arthritis

October 31, 2013 updated by: GlaxoSmithKline

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • GSK Investigational Site
  • Germany
      • Hamburg, Germany, 20249
        • GSK Investigational Site
      • Hamburg, Germany, 22081
        • GSK Investigational Site
    • Bayern
      • Augsburg, Bayern, Germany, 86179
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60433
        • GSK Investigational Site
      • Hofheim, Hessen, Germany, 65719
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • GSK Investigational Site
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • GSK Investigational Site
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • GSK Investigational Site
  • Hong Kong
      • Shatin, Hong Kong
        • GSK Investigational Site
  • Italy
    • Campania
      • Benevento, Campania, Italy, 82100
        • GSK Investigational Site
      • Telese Terme (BN), Campania, Italy, 82100
        • GSK Investigational Site
    • Marche
      • Jesi (AN), Marche, Italy, 60035
        • GSK Investigational Site
    • Puglia
      • Foggia, Puglia, Italy, 71100
        • GSK Investigational Site
    • Toscana
      • Pisa, Toscana, Italy, 56126
        • GSK Investigational Site
  • Norway
      • Drammen, Norway, N-3004
        • GSK Investigational Site
      • Lillehammer, Norway, 2609
        • GSK Investigational Site
      • Oslo, Norway, N-0027
        • GSK Investigational Site
      • Oslo, Norway, N-0370
        • GSK Investigational Site
      • Sarpsborg, Norway, N-1723
        • GSK Investigational Site
      • Stavanger, Norway, N-4011
        • GSK Investigational Site
      • Tønsberg, Norway, N-3117
        • GSK Investigational Site
  • Poland
      • Grudziadz, Poland, 86-300
        • GSK Investigational Site
      • Warszawa, Poland, 02-341
        • GSK Investigational Site
      • Wroclaw, Poland, 50-088
        • GSK Investigational Site
  • Spain
      • Baracaldo/Vizcaya, Spain, 48903
        • GSK Investigational Site
      • Granada, Spain, 18014
        • GSK Investigational Site
      • La Coruña, Spain, 15006
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Merida, Spain, 6800
        • GSK Investigational Site
      • Santiago de Compostela, Spain, 15706
        • GSK Investigational Site
      • Sevilla, Spain, 41071
        • GSK Investigational Site
      • Valencia, Spain, 46017
        • GSK Investigational Site
  • Sweden
      • Göteborg, Sweden, SE-431 45
        • GSK Investigational Site
      • Luleå, Sweden, SE-972 33
        • GSK Investigational Site
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • GSK Investigational Site
      • Sheffield, United Kingdom, S10 2JF
        • GSK Investigational Site
    • Lancashire
      • Wigan, Lancashire, United Kingdom, WN6 9EP
        • GSK Investigational Site
    • Merseyside
      • Wirral, Merseyside, United Kingdom, CH49 9PE
        • GSK Investigational Site
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2XU
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
28 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

April 28, 2006

First Submitted That Met QC Criteria

April 28, 2006

First Posted (Estimate)

May 3, 2006

Study Record Updates

Last Update Posted (Estimate)

November 3, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA1100849

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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