Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

NCT00209859 | Completed Phase 4

• 1 other identifier: 232-002
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• ACR20 response

Secondary Outcomes (4)

• ACR remission (modified)

• Cumulated dose of glucocorticoids

• Development of erosions

• Development of osteopenia

Interventions

Methotrexate DRUG

Intraarticular betamethasone DRUG

Cyclosporine/placebo-cyclosporine DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (6)

• 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.

  PMID: 30048002 DERIVED

• 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.

  PMID: 28391237 DERIVED

• 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.

  PMID: 22302316 DERIVED

• 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.

  PMID: 20436079 DERIVED

• 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.

  PMID: 20211020 DERIVED

• 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.

  PMID: 18388160 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate; Cyclosporine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Merete L Hetland, MD, PhD

  Hvidovre Univervsity Hospital

  PRINCIPAL INVESTIGATOR

• Kim Hørslev-Petersen, MD, DSc

  Rheumatism Hospital Graasten

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 1998
• Study Completion: November 1, 2007
• Last Updated: September 21, 2005

Record last verified: 2005-09

Locations

DK (1)