NCT00320450

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_2

Geographic Reach
9 countries

41 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

November 4, 2013

Status Verified

May 1, 2012

Enrollment Period

11 months

First QC Date

April 28, 2006

Last Update Submit

October 31, 2013

Conditions

Arthritis, Rheumatoid

Keywords

SB-681323CRPRheumatoid Arthritis SB-681323 CRP RARheumatoid ArthritisRA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

SB-681323DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

GSK Investigational Site

Hvidovre, 2650, Denmark

Location

GSK Investigational Site

Augsburg, Bavaria, 86179, Germany

Location

GSK Investigational Site

Hamburg, Hamburg, 20249, Germany

Location

GSK Investigational Site

Hamburg, Hamburg, 22081, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60433, Germany

Location

GSK Investigational Site

Hofheim, Hesse, 65719, Germany

Location

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

GSK Investigational Site

Halle, Saxony-Anhalt, 06120, Germany

Location

GSK Investigational Site

Kiel, Schleswig-Holstein, 24105, Germany

Location

GSK Investigational Site

Lübeck, Schleswig-Holstein, 23538, Germany

Location

GSK Investigational Site

Shatin, Hong Kong

Location

GSK Investigational Site

Foggia, Apulia, 71100, Italy

Location

GSK Investigational Site

Benevento, Campania, 82100, Italy

Location

GSK Investigational Site

Telese Terme (BN), Campania, 82100, Italy

Location

GSK Investigational Site

Jesi (AN), The Marches, 60035, Italy

Location

GSK Investigational Site

Pisa, Tuscany, 56126, Italy

Location

GSK Investigational Site

Drammen, N-3004, Norway

Location

GSK Investigational Site

Lillehammer, 2609, Norway

Location

GSK Investigational Site

Oslo, N-0027, Norway

Location

GSK Investigational Site

Oslo, N-0370, Norway

Location

GSK Investigational Site

Sarpsborg, N-1723, Norway

Location

GSK Investigational Site

Stavanger, N-4011, Norway

Location

GSK Investigational Site

Tønsberg, N-3117, Norway

Location

GSK Investigational Site

Grudziądz, 86-300, Poland

Location

GSK Investigational Site

Warsaw, 02-341, Poland

Location

GSK Investigational Site

Wroclaw, 50-088, Poland

Location

GSK Investigational Site

A Coruña, 15006, Spain

Location

GSK Investigational Site

Baracaldo/Vizcaya, 48903, Spain

Location

GSK Investigational Site

Granada, 18014, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Mérida, 6800, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

Location

GSK Investigational Site

Seville, 41071, Spain

Location

GSK Investigational Site

Valencia, 46017, Spain

Location

GSK Investigational Site

Gothenburg, SE-431 45, Sweden

Location

GSK Investigational Site

Luleå, SE-972 33, Sweden

Location

GSK Investigational Site

Wigan, Lancashire, WN6 9EP, United Kingdom

Location

GSK Investigational Site

Metropolitan Borough of Wirral, Merseyside, CH49 9PE, United Kingdom

Location

GSK Investigational Site

Edinburgh, Midlothian, EH4 2XU, United Kingdom

Location

GSK Investigational Site

London, SE1 9RT, United Kingdom

Location

GSK Investigational Site

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

dilmapimod

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2006

First Posted

May 3, 2006

Study Start

November 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

November 4, 2013

Record last verified: 2012-05

Locations

IT(5)HK(1)NO(7)DK(1)GB(5)DE(9)ES(8)SE(2)PL(3)