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

Rheumatoid Arthritis Clinical Trial

— PSARA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902005
• Other study ID #: S-07377b
• Status: Completed
• Phase: N/A
• First received: May 13, 2009
• Last updated: November 20, 2013
• Start date: April 2008
• Est. completion date: August 2012

Study information

• Verified date: November 2013
• Source: Revmatismesykehuset AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway: Directorate of HealthNorway: Norwegian Medicines AgencyNorway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: August 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Endothelial Dysfunction
• Inflammatory Disease Activity
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Norway	Lillehammer Hospital for Rheumatic Diseases	Lillehammer	Oppland

Sponsors (2)

Lead Sponsor	Collaborator
Revmatismesykehuset AS	Abbott

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline (before treatment starts), 6 weeks and 6 months after starting treatment	No
Secondary	CRP (C-reactive protein)		Baseline (before starting treatment), 6 weeks, 6 months after starting treatment	No
Secondary	DAS28 (Disease activity score)		Baseline (before starting treatment), 6 weeks, 6 months after starting treatment	No
Secondary	COMP (cartilage oligomeric matrix protein 1)		Baseline (before starting treatment), 6 weeks, 6 months after starting treatment	No
Secondary	IL-6 (interleukin 6)		Baseline (before starting treatment), 6 weeks, 6 months after starting treatment	No
Secondary	s-RAGE (Receptor of Advanced Glycation End products)		Baseline (before starting treatment), 6 weeks, 6 months after starting treatment	No