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

- ACR20 response
- ACR remission (modified)
- Cumulated dose of glucocorticoids
- Development of erosions
- Development of osteopenia

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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 |
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

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
Denmark | |
Hvidovre University Hospital | |
Hvidovre, Denmark, 2650 |
Principal Investigator: | Merete L Hetland, MD, PhD | Hvidovre Univervsity Hospital | |
Principal Investigator: | Kim Hørslev-Petersen, MD, DSc | Rheumatism Hospital Graasten |
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 |
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 |