Back to resultsMethotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Methotrexate
Intraarticular betamethasone
Cyclosporine/placebo-cyclosporine
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility 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
Sites / Locations
- Hvidovre University Hospital
Outcomes
Primary Outcome Measures
ACR20 response
Secondary Outcome Measures
ACR remission (modified)
Cumulated dose of glucocorticoids
Development of erosions
Development of osteopenia
Full Information
NCT ID
NCT00209859
First Posted
September 16, 2005
Last Updated
September 16, 2005
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00209859
Brief Title
Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis
Official Title
Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Drug
Intervention Name(s)
Intraarticular betamethasone
Intervention Type
Drug
Intervention Name(s)
Cyclosporine/placebo-cyclosporine
Primary Outcome Measure Information:
Title
ACR20 response
Secondary Outcome Measure Information:
Title
ACR remission (modified)
Title
Cumulated dose of glucocorticoids
Title
Development of erosions
Title
Development of osteopenia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete L Hetland, MD, PhD
Organizational Affiliation
Hvidovre Univervsity Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kim Hørslev-Petersen, MD, DSc
Organizational Affiliation
Rheumatism Hospital Graasten
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
30048002
Citation
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.
Results Reference
derived
PubMed Identifier
28391237
Citation
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.
Results Reference
derived
PubMed Identifier
22302316
Citation
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. Erratum In: Ann Rheum Dis. 2012 Nov;71(11):1918.
Results Reference
derived
PubMed Identifier
20436079
Citation
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.
Results Reference
derived
PubMed Identifier
20211020
Citation
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.
Results Reference
derived
PubMed Identifier
18388160
Citation
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.
Results Reference
derived
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Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis
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