Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis - Full Text View

Purpose

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	Intervention	Phase
Rheumatoid Arthritis	Drug: Methotrexate Drug: Intraarticular betamethasone Drug: Cyclosporine/placebo-cyclosporine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Betamethasone sodium phosphate Betamethasone Betamethasone valerate Betamethasone dipropionate Methotrexate sodium Cyclosporine

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:

ACR20 response

Secondary Outcome Measures:

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

Estimated Enrollment:	160
Study Start Date:	October 1998
Estimated Study Completion Date:	November 2007

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).

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209859

Locations

Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

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

More Information

No publications provided by Hvidovre University Hospital

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

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. Epub 2012 Feb 1.

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. 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. 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. Epub 2008 Apr 3.

ClinicalTrials.gov Identifier:	NCT00209859 History of Changes
Other Study ID Numbers:	232-002
Study First Received:	September 16, 2005
Last Updated:	September 16, 2005
Health Authority:	Denmark: Danish Medicines Agency

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Cyclosporins
Cyclosporine
Methotrexate
Anti-Inflammatory Agents

Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 21, 2013