A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid Arthritis

NCT00134693 | Completed Phase 2 DMC

• 1 other identifier: RA1104046
• Study Type: interventional
• Target: 77
• Locations: 5 countries
• Sites: 28

Brief Summary

This study is designed to compare a range of doses of SB-681323 with prednisolone, which has known effects on rheumatoid arthritis patients. By comparing the two drugs and their effects on blood proteins that indicate for rheumatoid arthritis, we hope to ascertain information on the most effective dose of SB-681323 to use in future.

Conditions

Arthritis, Rheumatoid

Keywords

SB-681323 rheumatoid arthritis CRP biomarkers

Outcome Measures

Primary Outcomes (1)

• Analysis for C-Reactive protein (CRP) levels 72 hours post-dose following SB-681323

  CRP levels were compared between SB-681323 and placebo 72 hours post-dose. The ratio of the dose response relationship of placebo and 7.5mg, 15mg and 25mg of SB-681323 has been presented.

  Day 3 (at 72 hour)

Secondary Outcomes (10)

• Analysis of CRP levels 24 and 48 hours post-dose following SB-681323

  Day 1 (at 24 hour) and Day 2 (at 48 hour)

• Analysis of Interleukin (IL)-6 levels up to 72 hours post-dose following SB-681323

  Upto Day 3 (at 1, 3, 24 and 72 hour)

• Number of participants with adverse events (AE) and serious adverse events (SAE)

  Upto Day 3 (72 hours)

• Change from Baseline in vital sign systolic blood pressure (SBP) and diastolic blood pressure (DBP)

  Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)

• Change from Baseline in vital sign heart rate

  Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)

Interventions

Prednisolone DRUG

SB-681323 DRUG

Also known as: Prednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.
• Must have 3 or more swollen or 3 or more tender/painful joints at screening.
• Must be on stable weekly methotrexate (2.5mg - 25mg) for at least eight weeks prior to screening.

You may not qualify if:

• Must not be morbidly obese.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (28)

GSK Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

GSK Investigational Site

Douglas, Queensland, 4814, Australia

Location

GSK Investigational Site

Woolloongabba, Queensland, 4102, Australia

Location

GSK Investigational Site

Daw Park, South Australia, 5041, Australia

Location

GSK Investigational Site

Woodville, South Australia, 5011, Australia

Location

GSK Investigational Site

Hobart, Tasmania, 7000, Australia

Location

GSK Investigational Site

Shenton Park, Western Australia, 6008, Australia

Location

GSK Investigational Site

Amiens, Picardie, 80054, France

Location

GSK Investigational Site

Montpellier, 34295, France

Location

GSK Investigational Site

Villingen-Schwenningen, Baden-Wurttemberg, 78054, Germany

Location

GSK Investigational Site

Hildesheim, Lower Saxony, 31134, Germany

Location

GSK Investigational Site

Chemnitz, Saxony, 09111, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04107, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04229, Germany

Location

GSK Investigational Site

Berlin, 12163, Germany

Location

GSK Investigational Site

Berlin, 13125, Germany

Location

GSK Investigational Site

Berlin, 14059, Germany

Location

GSK Investigational Site

Berlin, 14109, Germany

Location

GSK Investigational Site

Moscow, 115522, Russia

Location

GSK Investigational Site

Ryazan, 390026, Russia

Location

GSK Investigational Site

Yaroslavl, 150003, Russia

Location

GSK Investigational Site

Yekaterinburg, 620102, Russia

Location

GSK Investigational Site

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

GSK Investigational Site

Wigan, Lancashire, WN6 9EP, United Kingdom

Location

GSK Investigational Site

Liverpool, Merseyside, L9 7AL, United Kingdom

Location

GSK Investigational Site

Newcastle, Northumberland, NE1 4LP, United Kingdom

Location

GSK Investigational Site

Oxford, OX3 7LP, United Kingdom

Location

GSK Investigational Site

Sheffield, S10 2RX, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Prednisolone; dilmapimod

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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: August 24, 2005
• First Posted: August 25, 2005
• Study Start: June 21, 2005
• Primary Completion: August 3, 2006
• Study Completion: August 3, 2006
• Last Updated: July 31, 2017

Record last verified: 2017-07

Locations

AU (7); RU (4); FR (2); GB (6); DE (9)