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: October 31, 2013
Last verified: May 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
Denmark
GSK Investigational Site
Hvidovre, Denmark, 2650
Germany
GSK Investigational Site
Augsburg, Bayern, Germany, 86179
GSK Investigational Site
Frankfurt, Hessen, Germany, 60433
GSK Investigational Site
Hofheim, Hessen, Germany, 65719
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06120
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
GSK Investigational Site
Hamburg, Germany, 20249
GSK Investigational Site
Hamburg, Germany, 22081
Hong Kong
GSK Investigational Site
Shatin, Hong Kong
Italy
GSK Investigational Site
Benevento, Campania, Italy, 82100
GSK Investigational Site
Telese Terme (BN), Campania, Italy, 82100
GSK Investigational Site
Jesi (AN), Marche, Italy, 60035
GSK Investigational Site
Foggia, Puglia, Italy, 71100
GSK Investigational Site
Pisa, Toscana, Italy, 56126
Norway
GSK Investigational Site
Drammen, Norway, N-3004
GSK Investigational Site
Lillehammer, Norway, 2609
GSK Investigational Site
Oslo, Norway, N-0370
GSK Investigational Site
Oslo, Norway, N-0027
GSK Investigational Site
Sarpsborg, Norway, N-1723
GSK Investigational Site
Stavanger, Norway, N-4011
GSK Investigational Site
Tønsberg, Norway, N-3117
Poland
GSK Investigational Site
Grudziadz, Poland, 86-300
GSK Investigational Site
Warszawa, Poland, 02-341
GSK Investigational Site
Wroclaw, Poland, 50-088
Spain
GSK Investigational Site
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
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-431 45
GSK Investigational Site
Luleå, Sweden, SE-972 33
United Kingdom
GSK Investigational Site
Wigan, Lancashire, United Kingdom, WN6 9EP
GSK Investigational Site
Wirral, Merseyside, United Kingdom, CH49 9PE
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH4 2XU
GSK Investigational Site
London, United Kingdom, SE1 9RT
GSK Investigational Site
Sheffield, United Kingdom, S10 2JF
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: October 31, 2013
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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014