Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic Patients: The Influence of Antirheumatic Treatment (PSARA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Revmatismesykehuset AS.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Revmatismesykehuset AS
Collaborator:
Abbott
Information provided by:
Revmatismesykehuset AS
ClinicalTrials.gov Identifier:
NCT00902005
First received: May 13, 2009
Last updated: July 27, 2011
Last verified: May 2009
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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
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | December 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902005
Contacts
| Contact: Gunnbjørg Hjeltnes, MD | +47 61279500 | Gunn.Hjeltnes@Revmatismesykehuset.no |
| Contact: Knut Mikkelsen, MD | +47 61279500 | Knut.Mikkelsen@Revmatismesykehuset.no |
Locations
| Norway | |
| Lillehammer Hospital for Rheumatic Diseases | Recruiting |
| Lillehammer, Oppland, Norway, 2609 | |
| Contact: Gunnbjørg Hjeltnes, MD +47 61279500 Gunn.Hjeltnes@Revmatismesykehuset.no | |
| Contact: Knut Mikkelsen, MD +47 61279500 Knut.Mikkelsen@Revmatismesykehuset.no | |
| Principal Investigator: Gunnbjørg Hjeltnes, MD | |
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: | Knut Mikkelsen, MD, Lillehammer Hostpital for Rheumatic Diseases |
| ClinicalTrials.gov Identifier: | NCT00902005 History of Changes |
| Other Study ID Numbers: | S-07377b |
| Study First Received: | May 13, 2009 |
| Last Updated: | July 27, 2011 |
| 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, Psoriatic Arthritis Arthritis, Rheumatoid Spondylitis Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infection Ankylosis Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on June 18, 2013