Clinical trial NCT00320450: SB-681323 In Subjects With Rheumatoid Arthritis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: SB-681323
CRP
Rheumatoid Arthritis SB-681323 CRP RA
Rheumatoid Arthritis
RA
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 28 Days
Secondary outcomes:
measure: 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.
timeFrame: 28 Days
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: GSK Investigational Site
city: Augsburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hofheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Schwerin
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Halle
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Kiel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Shatin
country: Hong Kong
facility: GSK Investigational Site
city: Benevento
country: Italy
facility: GSK Investigational Site
state: Campania
city: Telese Terme (BN)
country: Italy
facility: GSK Investigational Site
state: Campania
city: Jesi (AN)
country: Italy
facility: GSK Investigational Site
state: Marche
city: Foggia
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Pisa
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Drammen
country: Norway
facility: GSK Investigational Site
city: Lillehammer
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Sarpsborg
country: Norway
facility: GSK Investigational Site
city: Stavanger
country: Norway
facility: GSK Investigational Site
city: Tønsberg
country: Norway
facility: GSK Investigational Site
city: Grudziadz
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Baracaldo/Vizcaya
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: La Coruña
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Merida
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Luleå
country: Sweden
facility: GSK Investigational Site
city: Wigan
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Wirral
country: United Kingdom
facility: GSK Investigational Site
state: Merseyside
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
state: Midlothian
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Sheffield
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: