Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis
NCT ID: NCT00209859
Last Updated: 2005-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
1998-10-31
2007-11-30
Brief Summary
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Detailed Description
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Selection of patients: Patients with recently diagnosed rheumatoid arthritis (less than 6 months of persistent synovitis).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Methotrexate
Intraarticular betamethasone
Cyclosporine/placebo-cyclosporine
Eligibility Criteria
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Inclusion Criteria
* Compliance with the ACR criteria for RA.
* Duration of no more than 6 months (from the first anamnestic non-traumatic synovitis of at least 6 weeks' duration).
* Informed consent.
Exclusion Criteria
* Lack of co-operability.
* Previous treatment with DMARD
* Corticosteroid treatment during the preceding 4 weeks.
* Contra indications for the treatments (awaiting the recommendations from Novartis)
* Previous or present malignant or premalignant disease
* Poorly regulated hypertension
* Impaired renal function
* Immuno defective diseases, including HIV
* Cardiac or pulmonary insufficiency
* Serious arteriosclerosis
* Serious granulocytopenia or thrombocytopenia
* Impaired liver function (liver enzymes more than twice the highest normal limit).
* Alcohol consumption of more than 3 drinks a week.
* Poorly controlled epilepsy
* Lack of contraception in fertile patients
* Pregnancy and lactation
* Psoriasis
* Poorly regulated diabetes
* Anticoagulant treatment
* Known allergy to the medicine
* Medicamental interactions
* Other inflammatory rheumatic diseases
18 Years
75 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Principal Investigators
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Merete L Hetland, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hvidovre Univervsity Hospital
Kim Hørslev-Petersen, MD, DSc
Role: PRINCIPAL_INVESTIGATOR
Rheumatism Hospital Graasten
Locations
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Hvidovre University Hospital
Hvidovre, , Denmark
Countries
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References
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Herly M, Stengaard-Pedersen K, Vestergaard P, Ostergaard M, Junker P, Hetland ML, Horslev-Petersen K, Ellingsen T. The D-vitamin metabolite 1,25(OH)2 D in serum is associated with disease activity and Anti-Citrullinated Protein Antibodies in active and treatment naive, early Rheumatoid Arthritis Patients. Scand J Immunol. 2018 Sep;88(3):e12704. doi: 10.1111/sji.12704. Epub 2018 Aug 22.
Herly M, Stengaard-Pedersen K, Horslev-Petersen K, Hetland ML, Ostergaard M, Christensen R, Logstrup BB, Vestergaard P, Podenphant J, Junker P, Ellingsen T. Association between baseline vitamin D metabolite levels and long-term cardiovascular events in patients with rheumatoid arthritis from the CIMESTRA trial: protocol for a cohort study with patient-record evaluated outcomes. BMJ Open. 2017 Apr 8;7(4):e014816. doi: 10.1136/bmjopen-2016-014816.
Hetland ML, Ostergaard M, Ejbjerg B, Jacobsen S, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Svendsen A, Pedersen JK, Skjodt H, Ellingsen T, Lindegaard H, Podenphant J, Horslev-Petersen K; CIMESTRA study group. Short- and long-term efficacy of intra-articular injections with betamethasone as part of a treat-to-target strategy in early rheumatoid arthritis: impact of joint area, repeated injections, MRI findings, anti-CCP, IgM-RF and CRP. Ann Rheum Dis. 2012 Jun;71(6):851-6. doi: 10.1136/annrheumdis-2011-200632. Epub 2012 Feb 1.
Christensen AF, Horslev-Petersen K, Christgau S, Lindegaard HM, Lottenburger T, Junker K, Hetland ML, Stengaard-Pedersen K, Jacobsen S, Ellingsen T, Andersen LS, Hansen I, Skjodt H, Pedersen JK, Lauridsen UB, Svendsen AJ, Tarp U, Podenphant J, Heegaard NH, Vestergaard A, Jurik AG, Ostergaard M, Junker P. Uncoupling of collagen II metabolism in newly diagnosed, untreated rheumatoid arthritis is linked to inflammation and antibodies against cyclic citrullinated peptides. J Rheumatol. 2010 Jun;37(6):1113-20. doi: 10.3899/jrheum.091265. Epub 2010 May 1.
Christensen AF, Sorensen GL, Horslev-Petersen K, Holmskov U, Lindegaard HM, Junker K, Hetland ML, Stengaard-Pedersen K, Jacobsen S, Lottenburger T, Ellingsen T, Andersen LS, Hansen I, Skjodt H, Pedersen JK, Lauridsen UB, Svendsen A, Tarp U, Podenphant J, Vestergaard A, Jurik AG, Ostergaard M, Junker P. Circulating surfactant protein -D is low and correlates negatively with systemic inflammation in early, untreated rheumatoid arthritis. Arthritis Res Ther. 2010;12(2):R39. doi: 10.1186/ar2948. Epub 2010 Mar 8.
Hetland ML, Ejbjerg B, Horslev-Petersen K, Jacobsen S, Vestergaard A, Jurik AG, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Skjodt H, Pedersen JK, Majgaard O, Svendsen AJ, Ellingsen T, Lindegaard H, Christensen AF, Vallo J, Torfing T, Narvestad E, Thomsen HS, Ostergaard M; CIMESTRA study group. MRI bone oedema is the strongest predictor of subsequent radiographic progression in early rheumatoid arthritis. Results from a 2-year randomised controlled trial (CIMESTRA). Ann Rheum Dis. 2009 Mar;68(3):384-90. doi: 10.1136/ard.2008.088245. Epub 2008 Apr 3.
Other Identifiers
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232-002
Identifier Type: -
Identifier Source: org_study_id