- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001677
Methotrexate Alone Versus Combination of Methotrexate and Subcutaneous Fludarabine for Severe Rheumatoid Arthritis: Safety, Tolerance and Efficacy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Ability to provide informed consent to all aspects of the study after full information is provided.
Age equal to or older than 18.
A diagnosis of Rheumatoid Arthritis (RA) of more than 6 months as defined by the revised American College of Rheumatology criteria.
Active RA defined as: 6 or more swollen joints;
6 or more tender joints;
ESR greater than 28 mm/hr (or CRP greater than 0.8) or morning stiffness greater than 45 minutes.
Incomplete response (defined as persistently active disease as described above) to treatment with at least one of the following regimens for over 3 months:
MTX alone (greater than or equal to 17.5 mg/week);
MTX (greater than or equal to 17.5 mg/week) plus HCQ (greater than or equal to 200 mg/day);
MTX (greater than or equal to 17.5 mg/week) plus SSZ (greater than or equal to 1 gm/d);
MTX (greater than or equal to 17.5 mg/week) plus CsA (1-3 mg/kg/day);
MTX (greater than or equal to 17.5 mg/week) plus SSZ (greater than 1 gm/day) plus HCQ (greater than or equal to 200 mg/day);
No requirement of corticosteroids in doses equivalent to over 10 mg/d prednisone nor other immunosuppressive agents required for the control of extraarticular manifestations at the time of study entry.
No active acute or chronic infections requiring antibiotic therapy, serious viral infections (such as hepatitis, herpes zoster, or HIV), or serious fungal infections. Patients with a positive PPD who have not received INH or other antituberculous therapy will be excluded.
No pregnant women, nursing mothers, or patients of childbearing age not practicing birth control.
No preexisting malignancy other than basal cell carcinoma.
No history of stroke, seizure disorder, or chronic neurologic disease.
No unstable coronary artery disease, cardiomyopathy, conduction heart block greater than first degree, or a dysrhythmia requiring therapy.
No confounding medical illness that in the judgment of the investigators would pose added risk for study participants (e.g., chronic hepatic, renal, or pulmonary disease or bone marrow hypoplasia).
No presence of seronegative spondyloarthropathy, systemic lupus erythematosus, systemic sclerosis, inflammatory myopathy, systemic vasculitis, psoriasis, or inflammatory bowel disease.
No serum creatinine greater than 2.0 mg/dL on at least 2 different occasions which is sustained for at least 1 month.
No hematocrit less than 28% (or hemoglobin less than 9.0 mg/dL), or platelet count less than 100,000, or white blood count less than 3,500/dL.
No patients with active lung disease, patients with a chronic and progressive lung disease, or patients with a chronic but stable lung disease with pulmonary function tests of less than 70% of predicted (DLCO less than 60%).
No patients with hypogammaglobulinemia (IgG count less than 300).
No patients treated with alkylating agents for over 1 year at any time or treated with a purine nucleoside analog at any time.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Publications and helpful links
General Publications
- Priebe T, Platsoucas CD, Seki H, Fox FE, Nelson JA. Purine nucleoside modulation of functions of human lymphocytes. Cell Immunol. 1990 Sep;129(2):321-8. doi: 10.1016/0008-8749(90)90208-9.
- Davis JC Jr, Fessler BJ, Tassiulas IO, McInnes IB, Yarboro CH, Pillemer S, Wilder R, Fleisher TA, Klippel JH, Boumpas DT. High dose versus low dose fludarabine in the treatment of patients with severe refractory rheumatoid arthritis. J Rheumatol. 1998 Sep;25(9):1694-704.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Synovitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Fludarabine
- Methotrexate
Other Study ID Numbers
- 980117
- 98-AR-0117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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