NCT00330889

Brief Summary

This study will assess the Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of Prednisolone on Rheumatoid Arthritis (RA) patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2004

Typical duration for all trials

Geographic Reach
3 countries

6 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

February 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 22, 2012

Status Verified

October 1, 2012

Enrollment Period

2.8 years

First QC Date

May 26, 2006

Last Update Submit

October 18, 2012

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • Modified Disease Activity Score (DAS28), which was composed of swollen and tender joint counts at 28 sites, a patient's global assessment of disease activity using a visual analogue scale (VAS), and ESR.

    14 days

  • The levels of selected markers of inflammation, which could include (but were not limited to) ESR, C-reactive protein (CRP), interleukin-6 (IL-6), Rheumatoid factor (RF), and soluble tumor necrosis factor-receptor (TNF-R)

    14 days

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients and pharmacodynamic effects on whole blood gene and protein expression.

You may qualify if:

  • Meet the ACR criteria for diagnosis of rheumatoid arthritis.
  • Required treatment with Prednisolone.
  • Currently on a non-steroidal anti-inflammatory agent (NSAID).
  • Willing to stay on current dose of NSAID for two weeks during study.

You may not qualify if:

  • Major health issues such as osteoporosis, diabetes, heart failure, heart attack, kidney failure, or acute infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

GSK Investigational Site

Birmingham, Alabama, 35249, United States

Location

GSK Investigational Site

Los Angeles, California, 90095, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68198, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

GSK Investigational Site

Winnipeg, Manitoba, R3A-1M4, Canada

Location

GSK Investigational Site

Sheffield, S10 2RX, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

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
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2006

First Posted

May 29, 2006

Study Start

February 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

October 22, 2012

Record last verified: 2012-10

Locations

US(4)CA(1)GB(1)