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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Revmatismesykehuset AS
ClinicalTrials.gov Identifier:
NCT00902005
First received: May 13, 2009
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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).


Condition
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Endothelial Dysfunction
Inflammatory Disease Activity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Revmatismesykehuset AS:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CRP (C-reactive protein) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ] [ Designated as safety issue: No ]
  • DAS28 (Disease activity score) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ] [ Designated as safety issue: No ]
  • COMP (cartilage oligomeric matrix protein 1) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ] [ Designated as safety issue: No ]
  • IL-6 (interleukin 6) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ] [ Designated as safety issue: No ]
  • s-RAGE (Receptor of Advanced Glycation End products) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 145
Study Start Date: April 2008
Study Completion Date: August 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902005

Locations
Norway
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, Oppland, Norway, 2609
Sponsors and Collaborators
Revmatismesykehuset AS
Abbott
Investigators
Study Chair: Knut Mikkelsen, MD Lillehammer Hospital for Rheumatic Diseases
Principal Investigator: Gunnbjørg Hjeltnes, MD Lillehammer Hospital for Rheumatic Diseases
  More Information

No publications provided by Revmatismesykehuset AS

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Revmatismesykehuset AS
ClinicalTrials.gov Identifier: NCT00902005     History of Changes
Other Study ID Numbers: S-07377b
Study First Received: May 13, 2009
Last Updated: November 20, 2013
Health Authority: Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Revmatismesykehuset AS:
Endothelial dysfunction
Bone and cartilage markers
Inflammatory disease activity
Rheumatoid arthritis
Psoriatic arthritis
Ankylosing Spondylitis

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Autoimmune Diseases
Bone Diseases
Bone Diseases, Infectious
Connective Tissue Diseases
Immune System Diseases
Infection
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Rheumatic Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014