Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00209859

Recruitment Status : Completed

First Posted : September 21, 2005

Last Update Posted : September 21, 2005

Sponsor:

Information provided by:

Hvidovre University Hospital

Study Description

Brief Summary:

To investigate whether cyclosporine, added to methotrexate and steroid, increases the possibility of inflammatory management early in the disease; furthermore to investigate the possible steroid-sparing effect of cyclosporine in patients with recently diagnosed rheumatoid arthritis.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: Methotrexate Drug: Intraarticular betamethasone Drug: Cyclosporine/placebo-cyclosporine	Phase 4

Detailed Description:

Design: Multicentre, prospective, randomised, double-blind study with parallel design.

Selection of patients: Patients with recently diagnosed rheumatoid arthritis (less than 6 months of persistent synovitis).

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	160 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.
Study Start Date :	October 1998
Study Completion Date :	November 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rheumatoid arthritis

MedlinePlus related topics: Arthritis Rheumatoid Arthritis

Drug Information available for: Methotrexate Cyclosporine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

ACR20 response

Secondary Outcome Measures :

ACR remission (modified)
Cumulated dose of glucocorticoids
Development of erosions
Development of osteopenia

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Synovitis in at least 2 joints.
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:

Age less than 18 years or more than 75 years
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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209859

Locations

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Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

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Principal Investigator:	Merete L Hetland, MD, PhD	Hvidovre Univervsity Hospital
Principal Investigator:	Kim Hørslev-Petersen, MD, DSc	Rheumatism Hospital Graasten

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Herly M, Stengaard-Pedersen K, Vestergaard P, Østergaard M, Junker P, Hetland ML, Hørslev-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 naïve, 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, Hørslev-Petersen K, Hetland ML, Østergaard M, Christensen R, Løgstrup BB, Vestergaard P, Pødenphant 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, Østergaard M, Ejbjerg B, Jacobsen S, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Svendsen A, Pedersen JK, Skjødt H, Ellingsen T, Lindegaard H, Pødenphant J, Hørslev-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. Erratum in: Ann Rheum Dis. 2012 Nov;71(11):1918.

Christensen AF, Hørslev-Petersen K, Christgau S, Lindegaard HM, Lottenburger T, Junker K, Hetland ML, Stengaard-Pedersen K, Jacobsen S, Ellingsen T, Andersen LS, Hansen I, Skjødt H, Pedersen JK, Lauridsen UB, Svendsen AJ, Tarp U, Pødenphant 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, Sørensen GL, Hørslev-Petersen K, Holmskov U, Lindegaard HM, Junker K, Hetland ML, Stengaard-Pedersen K, Jacobsen S, Lottenburger T, Ellingsen T, Andersen LS, Hansen I, Skjødt H, Pedersen JK, Lauridsen UB, Svendsen A, Tarp U, Pødenphant J, Vestergaard A, Jurik AG, Østergaard 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, Hørslev-Petersen K, Jacobsen S, Vestergaard A, Jurik AG, Stengaard-Pedersen K, Junker P, Lottenburger T, Hansen I, Andersen LS, Tarp U, Skjødt H, Pedersen JK, Majgaard O, Svendsen AJ, Ellingsen T, Lindegaard H, Christensen AF, Vallø 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.

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ClinicalTrials.gov Identifier:	NCT00209859
Other Study ID Numbers:	232-002
First Posted:	September 21, 2005 Key Record Dates
Last Update Posted:	September 21, 2005
Last Verified:	September 2005

Additional relevant MeSH terms:

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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Cyclosporine Betamethasone Methotrexate Cyclosporins Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents	Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Antifungal Agents Anti-Infective Agents Calcineurin Inhibitors

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