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Completed

NCT Number: NCT00902005

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

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).

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Key information

Conditions

Rheumatoid Arthritis Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Endothelial Dysfunction Immune System Diseases Inflammatory Disease Activity Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lillehammer Hospital for Rheumatic Diseases

Lillehammer, Oppland, 2609, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. CRP (C-reactive protein)

    Time frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment

  2. DAS28 (Disease activity score)

    Time frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment

  3. COMP (cartilage oligomeric matrix protein 1)

    Time frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment

  4. IL-6 (interleukin 6)

    Time frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment

  5. s-RAGE (Receptor of Advanced Glycation End products)

    Time frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment

Sponsors and collaborators

Lead sponsor

Revmatismesykehuset AS

Other

Collaborators

  • Abbott

Registry information

Official study 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

Acronym: PSARA

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
May 14, 2009
Registry last updated
Nov 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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