search
Back to results

SB-681323 In Subjects With Rheumatoid Arthritis

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SB-681323
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring SB-681323, CRP, Rheumatoid Arthritis SB-681323 CRP RA, Rheumatoid Arthritis, RA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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.

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.

Full Information

First Posted
April 28, 2006
Last Updated
October 31, 2013
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00320450
Brief Title
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

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
SB-681323, CRP, Rheumatoid Arthritis SB-681323 CRP RA, Rheumatoid Arthritis, RA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SB-681323
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
GSK Investigational Site
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86179
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60433
Country
Germany
Facility Name
GSK Investigational Site
City
Hofheim
State/Province
Hessen
ZIP/Postal Code
65719
Country
Germany
Facility Name
GSK Investigational Site
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19055
Country
Germany
Facility Name
GSK Investigational Site
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
GSK Investigational Site
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
GSK Investigational Site
City
Luebeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
GSK Investigational Site
City
Shatin
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Benevento
State/Province
Campania
ZIP/Postal Code
82100
Country
Italy
Facility Name
GSK Investigational Site
City
Telese Terme (BN)
State/Province
Campania
ZIP/Postal Code
82100
Country
Italy
Facility Name
GSK Investigational Site
City
Jesi (AN)
State/Province
Marche
ZIP/Postal Code
60035
Country
Italy
Facility Name
GSK Investigational Site
City
Foggia
State/Province
Puglia
ZIP/Postal Code
71100
Country
Italy
Facility Name
GSK Investigational Site
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
GSK Investigational Site
City
Drammen
ZIP/Postal Code
N-3004
Country
Norway
Facility Name
GSK Investigational Site
City
Lillehammer
ZIP/Postal Code
2609
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
N-0027
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
N-0370
Country
Norway
Facility Name
GSK Investigational Site
City
Sarpsborg
ZIP/Postal Code
N-1723
Country
Norway
Facility Name
GSK Investigational Site
City
Stavanger
ZIP/Postal Code
N-4011
Country
Norway
Facility Name
GSK Investigational Site
City
Tønsberg
ZIP/Postal Code
N-3117
Country
Norway
Facility Name
GSK Investigational Site
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
02-341
Country
Poland
Facility Name
GSK Investigational Site
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
GSK Investigational Site
City
Baracaldo/Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
GSK Investigational Site
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
GSK Investigational Site
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Merida
ZIP/Postal Code
6800
Country
Spain
Facility Name
GSK Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
GSK Investigational Site
City
Göteborg
ZIP/Postal Code
SE-431 45
Country
Sweden
Facility Name
GSK Investigational Site
City
Luleå
ZIP/Postal Code
SE-972 33
Country
Sweden
Facility Name
GSK Investigational Site
City
Wigan
State/Province
Lancashire
ZIP/Postal Code
WN6 9EP
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Wirral
State/Province
Merseyside
ZIP/Postal Code
CH49 9PE
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

SB-681323 In Subjects With Rheumatoid Arthritis

We'll reach out to this number within 24 hrs