Rheumatoid ArthritisPSARANCT00902005
Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic Patients: The Influence of Antirheumatic Treatment
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Revmatismesykehuset AS at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- How many people
- 145 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2008to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, Oppland, 2609
About this study
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
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).
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Endothelial Dysfunction, Inflammatory Disease Activity
- Keywords
- Endothelial dysfunction, Bone and cartilage markers, Inflammatory disease activity, Rheumatoid arthritis, Psoriatic arthritis, Ankylosing Spondylitis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (before treatment starts), 6 weeks and 6 months after starting treatment
Secondary outcomes (5)
CRP (C-reactive protein)
Measured: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment
DAS28 (Disease activity score)
Measured: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment
COMP (cartilage oligomeric matrix protein 1)
Measured: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment
IL-6 (interleukin 6)
Measured: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment
s-RAGE (Receptor of Advanced Glycation End products)
Measured: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startApr 2008
- Primary completionJun 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revmatismesykehuset AS
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Knut Mikkelsen, MD, Study chair, Lillehammer Hospital for Rheumatic DiseasesGunnbjørg Hjeltnes, MD, Principal investigator, Lillehammer Hospital for Rheumatic Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902005
- Sponsor's protocol ID
- S-07377b
- Acronym
- PSARA
- Status last verified
- Nov 2013
- First submitted
- 13 May 2009
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hokstad I, Deyab G, Wang Fagerland M, Lyberg T, Hjeltnes G, Forre O, Agewall S, Mollnes TE, Hollan I. Tumor necrosis factor inhibitors are associated with reduced complement activation in spondylarthropathies: An observational study. PLoS One. 2019 Jul 23;14(7):e0220079. doi: 10.1371/journal.pone.0220079. eCollection 2019.
PubMed 31335881Deyab G, Hokstad I, Whist JE, Smastuen MC, Agewall S, Lyberg T, Ronda N, Mikkelsen K, Hjeltnes G, Hollan I. Methotrexate and anti-tumor necrosis factor treatment improves endothelial function in patients with inflammatory arthritis. Arthritis Res Ther. 2017 Oct 17;19(1):232. doi: 10.1186/s13075-017-1439-1.
PubMed 29041979Ronda N, Greco D, Adorni MP, Zimetti F, Favari E, Hjeltnes G, Mikkelsen K, Borghi MO, Favalli EG, Gatti R, Hollan I, Meroni PL, Bernini F. Newly identified antiatherosclerotic activity of methotrexate and adalimumab: complementary effects on lipoprotein function and macrophage cholesterol metabolism. Arthritis Rheumatol. 2015 May;67(5):1155-64. doi: 10.1002/art.39039.
PubMed 25605003Hjeltnes G, Hollan I, Forre O, Wiik A, Lyberg T, Mikkelsen K, Agewall S. Relations of serum COMP to cardiovascular risk factors and endothelial function in patients with rheumatoid arthritis treated with methotrexate and TNF-alpha inhibitors. J Rheumatol. 2012 Jul;39(7):1341-7. doi: 10.3899/jrheum.111401. Epub 2012 Jun 1.
PubMed 22660798
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00902005
- Acronym / sponsor ID
- PSARA / S-07377b
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Endothelial Dysfunction, Inflammatory Disease Activity
- Keywords
- Endothelial dysfunction, Bone and cartilage markers, Inflammatory disease activity, Rheumatoid arthritis, Psoriatic arthritis, Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Revmatismesykehuset ASUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Apr 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 14 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
- Derived from this study: PubMed 31335881Hokstad I, Deyab G, Wang Fagerland M, Lyberg T, Hjeltnes G, Forre O, Agewall S, Mollnes TE, Hollan I. Tumor necrosis factor inhibitors are associated with reduced complement activation in spondylarthropathies: An observational study. PLoS One. 2019 Jul 23;14(7):e0220079. doi: 10.1371/journal.pone.0220079. eCollection 2019.
- Derived from this study: PubMed 29041979Deyab G, Hokstad I, Whist JE, Smastuen MC, Agewall S, Lyberg T, Ronda N, Mikkelsen K, Hjeltnes G, Hollan I. Methotrexate and anti-tumor necrosis factor treatment improves endothelial function in patients with inflammatory arthritis. Arthritis Res Ther. 2017 Oct 17;19(1):232. doi: 10.1186/s13075-017-1439-1.
- Derived from this study: PubMed 25605003Ronda N, Greco D, Adorni MP, Zimetti F, Favari E, Hjeltnes G, Mikkelsen K, Borghi MO, Favalli EG, Gatti R, Hollan I, Meroni PL, Bernini F. Newly identified antiatherosclerotic activity of methotrexate and adalimumab: complementary effects on lipoprotein function and macrophage cholesterol metabolism. Arthritis Rheumatol. 2015 May;67(5):1155-64. doi: 10.1002/art.39039.
- Derived from this study: PubMed 22660798Hjeltnes G, Hollan I, Forre O, Wiik A, Lyberg T, Mikkelsen K, Agewall S. Relations of serum COMP to cardiovascular risk factors and endothelial function in patients with rheumatoid arthritis treated with methotrexate and TNF-alpha inhibitors. J Rheumatol. 2012 Jul;39(7):1341-7. doi: 10.3899/jrheum.111401. Epub 2012 Jun 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut Mikkelsen, MD study chair
Lillehammer Hospital for Rheumatic Diseases
Gunnbjørg Hjeltnes, MD principal investigator
Lillehammer Hospital for Rheumatic Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Revmatismesykehuset AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00902005, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.