Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis

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).

Herly M, Stengaard-Pedersen K, Stengaard-Pedersen K, Vestergaard P, Østergaard M, Junker P, Hetland ML, Hørslev-Petersen K, Ellingsen T.

2018-08-2214 citations

10.1111/sji.12704

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

M. Herly, Kristian Stengaard‐Pedersen, Kim Hørslev‐Petersen, Merete Lund Hetland, Mikkel Østergaard et al. (11 authors)

BMJ Open2017-04-015 citations

10.1136/bmjopen-2016-014816

Uncoupling of collagen II metabolism in newly diagnosed, untreated rheumatoid arthritis is linked to inflammation and antibodies against cyclic citrullinated peptides.

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.

2010-05-0112 citations

10.3899/jrheum.091265

Circulating surfactant protein -D is low and correlates negatively with systemic inflammation in early, untreated rheumatoid arthritis.

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.

2010-03-0816 citations

10.1186/ar2948

MRI bone oedema is the strongest predictor of subsequent radiographic progression in early rheumatoid arthritis. Results from a 2-year randomised controlled trial (CIMESTRA).

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.

2008-04-03256 citations

10.1136/ard.2008.088245

Interventions

DRUGMethotrexate

DRUGIntraarticular betamethasone

DRUGCyclosporine/placebo-cyclosporine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
ACR20 response	—

Secondary

Measure	Time frame
ACR remission (modified)	—
Cumulated dose of glucocorticoids	—
Development of erosions	—
Development of osteopenia	—

Countries

Denmark

Outcome results

None listed