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Trial record 1 of 1 for:    00902005
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Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic Patients: The Influence of Antirheumatic Treatment (PSARA)

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ClinicalTrials.gov Identifier: NCT00902005
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : November 21, 2013
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Revmatismesykehuset AS

Tracking Information
First Submitted Date May 13, 2009
First Posted Date May 14, 2009
Last Update Posted Date November 21, 2013
Study Start Date April 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2009)
To examine the association between inflammatory disease activity and endothelial function in RA and spondyloarthritis patients treated with methotrexate and TNFalpha-inhibitor in combination or methotrexate or TNFalpha-inhibitor alone [ Time Frame: Baseline (before treatment starts), 6 weeks and 6 months after starting treatment ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 13, 2009)
  • CRP (C-reactive protein) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ]
  • DAS28 (Disease activity score) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ]
  • COMP (cartilage oligomeric matrix protein 1) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ]
  • IL-6 (interleukin 6) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ]
  • s-RAGE (Receptor of Advanced Glycation End products) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic Patients: The Influence of Antirheumatic Treatment
Official Title Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in RA and Spondyloarthritis Patients, Treated With TNFalpha-inhibitors in Combination With Methotrexate or Methotrexate or TNFalpha-inhibitors Alone - a Prospective Study
Brief Summary The aim of this study is to examine the associations between inflammatory disease activity and endothelial function in rheumatoid arthritis (RA) and spondyloarthritis patients treated with methotrexate and Tumor Necrosis Factor alpha (TNFalpha)inhibitor in combination or methotrexate or TNFalpha-inhibitor alone. Further, to look for improvement in endothelial function, and decrease in bone and cartilage destruction during treatment with the combination therapy of TNFalpha-inhibitor and methotrexate in RA and Psoriatic Arthritis (PSA) patients. Last, examine the TNFalpha inhibitors influence on endothelial function and levels of bone and cartilage markers in patients with Ankylosing Spondylitis (AS).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood
Sampling Method Non-Probability Sample
Study Population Patients with RA and spondyloarthritis starting with either combination therapy of TNFalpha-inhibitor and methotrexate or methotrexate or TNFalpha-inhibitor alone, at Lillehammer Hospital for Rheumatic diseases.Decision about treatment modality will be based on conventional clinial judgement.
Condition
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Ankylosing Spondylitis
  • Endothelial Dysfunction
  • Inflammatory Disease Activity
Intervention Not Provided
Study Groups/Cohorts Rheumatic patients

Three groups:

RA patients: 30 starting on Methotrexate, 30 starting on combination of Methotrexate and TNFalpha inhibitor.

PSA patients: 20 starting on Methotrexate, 20 starting on combination of Methotrexate and TNFalpha inhibitor.

AS patients: 20 starting on TNFalpha inhibitor

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 20, 2013)
145
Original Estimated Enrollment
 (submitted: May 13, 2009)
120
Actual Study Completion Date August 2012
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Males and females 18-80 years
  • Able and willing to give written informed consent, and to comply with the requirements of the study protocol.
  • Fulfilling the ACR 1987 revised diagnostic criteria for the diagnosis rheumatoid arthritis, or the diagnostic criteria by Moll and Wright for the diagnosis psoriatic arthritis, or the modified New York diagnostic criteria for ankylosing spondylitis.
  • Clinical indication for starting treatment with methotrexate, TNFalpha- inhibitor or combination therapy.
  • Use of reliable method of contraception for women with childbearing potential.

Exclusion Criteria:

  • Lack of cooperativity
  • Positive serology for hepatitis B or C
  • History of positive HIV status.
  • History of tuberculosis or untreated tuberculosis.
  • PPD more than 15 mm in previously BCG immunized subjects. PPD 6 mm or more if not previously BCG immunized.
  • Histoplasmosis or Listeriosis
  • Persistent or recurrent infections
  • Any inflammatory disease of permanence not related to RA, PSA or AS.
  • Pregnancy or breast-feeding.
  • Use of prednisolone more than 10 mg daily for 2 weeks at inclusion.
  • Use of TNFalpha-inhibitor the last 4 weeks.
  • History of cancer.
  • Uncontrolled diabetes.
  • Congestive heart failure (Nyha 3-4)
  • Recent stroke (within 3 months)
  • Previous diagnosis or signs of central nervous system demyelinating disease.
  • Previously diagnosed immunodeficiency.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT00902005
Other Study ID Numbers S-07377b
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Revmatismesykehuset AS
Study Sponsor Revmatismesykehuset AS
Collaborators Abbott
Investigators
Study Chair: Knut Mikkelsen, MD Lillehammer Hospital for Rheumatic Diseases
Principal Investigator: Gunnbjørg Hjeltnes, MD Lillehammer Hospital for Rheumatic Diseases
PRS Account Revmatismesykehuset AS
Verification Date November 2013