SB-681323 In Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320450
• Other study ID #: RA1100849
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2006
• Last updated: October 31, 2013
• Start date: November 2005
• Est. completion date: October 2006

Study information

• Verified date: May 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• SB-681323

Locations

Country	Name	City	State
Denmark	GSK Investigational Site	Hvidovre
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Halle	Sachsen-Anhalt
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hofheim	Hessen
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern
Hong Kong	GSK Investigational Site	Shatin
Italy	GSK Investigational Site	Benevento	Campania
Italy	GSK Investigational Site	Foggia	Puglia
Italy	GSK Investigational Site	Jesi (AN)	Marche
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Telese Terme (BN)	Campania
Norway	GSK Investigational Site	Drammen
Norway	GSK Investigational Site	Lillehammer
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Sarpsborg
Norway	GSK Investigational Site	Stavanger
Norway	GSK Investigational Site	Tønsberg
Poland	GSK Investigational Site	Grudziadz
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wroclaw
Spain	GSK Investigational Site	Baracaldo/Vizcaya
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	La Coruña
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Merida
Spain	GSK Investigational Site	Santiago de Compostela
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Valencia
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Luleå
United Kingdom	GSK Investigational Site	Edinburgh	Midlothian
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Sheffield
United Kingdom	GSK Investigational Site	Wigan	Lancashire
United Kingdom	GSK Investigational Site	Wirral	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Denmark,  Germany,  Hong Kong,  Italy,  Norway,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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