|
A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis Clinical research trials and A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis. A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis clinical trial. Participants oftentimes recieve the finest healthcare available for their A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis  A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis
A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis
For Condition: Arthritis, Psoriatic,Psoriasis
Status: Completed
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: This is a placebo controlled study evaluating the role of fludarabine (a nucleoside analog targeting both resting and proliferating lymphocytes) in the treatment of moderate to severe psoriotic arthritis. Patients should have failed at least one disease modifying antirheumatic drug.
Details: The efficacy and toxicity of immunosuppressive therapy using the adenine analogue fludarabine will be evaluated in 20 patients with psoriatic arthritis, who have failed or have developed intolerable side-effects to at least one disease modifying antirheumatic drug including sulfasalazine, gold, methoxypsoralen and long wave ultraviolet A light (PUVA), retinoids, methotrexate or cyclosporin. In this double-blind, placebo-controlled trial patients will receive a four month course of intravenous fludarabine (30 mg/m(2)/day for 2-3 days every 4 weeks for a total of four cycles) or placebo by a block randomization procedure to ensure groups balanced for disease activity. After a washout period of two months, the patients receiving placebo will have the option of crossing over to the fludarabine arm for an additional four months of treatment. Disease activity (both skin and joints) will be monitored throughout the study. At the end of the study, physician and patient assessment of disease activity as well as drug-related toxicities will be analyzed.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Ability to provide informed consent to all aspects of the study after full information is provided. Age equal to or older than 18 years. Psoriatic arthritis of more than 6 months duration defined by the following criteria: A psoriatic skin lesion (or history of psoriatic skin lesion documented by a physician) with or without nail involvement. Peripheral arthritis alone or in combination with sacroiliitis. Patients with chest expansion less than 2.5 cm or decreased flexion of the cervical and lumbosacral spine flexion by 50% or more will be excluded. A negative serum test for rheumatoid factor and absence of subcutaneous nodules. Radiographic findings (if present) compatible with psoriatic arthritis ("pencil in cup lesion," osteolysis of the terminal phalanx, asymmetrical sacroiliitis, erosive oligoarticular arthritis or spinal syndesmophytes). Criteria a-c are required for diagnosis whereas criterion d is optional. Active arthritis with 3 or more painful or swollen joints considered capable of responding to drug therapy and at least 2 of the following: Tenderness or pain on movement of at least 3 joints (or periarticular areas). 30 minutes of morning stiffness (in peripheral joints or in the spine). Erythrocyte sedimentation rate (ESR) greater than or equal to 28mm/hour or C-reactive protein (CRP) greater than 0.8 mg/dl. Failure to respond or development of intolerable side effects to at least one of the following treatments: sulfasalazine, gold retinoids, PUVA, methotrexate, azathioprine or cyclosporin. A waiting period of equal to or greater than 4 weeks after the end of previous systemic treatment will be required before initiation of fludarabine treatment. Topical treatment for psoriasis (glucocorticoids, tar, anthralin, etc.) should be discontinued 2 weeks prior to study entry. not have seropositive, symmetric polyarthritis. Must not have the spondylitic form of psoriatic arthritis (spondylitis alone or in combination with shoulder and hip arthritis). Must not have arthritis mutilans. Must not be receiving glucocorticoids in doses greater than 10mg/day of prednisone. Patients must not have acute or chronic infections requiring antimicrobial therapy or serious viral (e.g., hepatitis, herpes zoster or HIV infections) or fungal infections. Patients with a positive PPD who have not received INH or other antituberculous therapy may be excluded if in the opinion of an infectious disease consultant immunosuppressive therapy is contraindicated. Females must not be pregnant or lactating. Females of childbearing age must be practicing birth control. No pre-existing malignancy other than basal cell carcinoma. All females must have a negative Papanicolaou smear within a 3 month period prior to study entry. No history of cerebrovascular accidents, seizure disorder or chronic neurologic disease. No history of documented coronary artery disease, cardiomyopathy or 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 (PFTs less than 70% of predicted value or DLCO less than 60%) or bone marrow hypoplasia (Hb less than 10 mg/dl, platelets less than 100.000/dl or WBC less than 3.400/dl). No patients who have received alkylating agents for greater than or equal to 1 year. No patients with creatinine clearance (CrCl) less than 50 ml/min.
Total Enrollment: 20
Location and Contact Information:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 950140; 95-AR-0140
Study Start Date: June 17, 1995
Record last reviewed: May 11, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001422
Other Arthritis, Psoriatic Studies:
1. Conditioning, the Placebo Effect, and Psoriasis
2. Scalp Psoriasis Treatment with a Fiber Optic Comb
3. Study of Psoriatic Arthritis
4. A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients
5. Treatment of Psoriasis Using Acitretin in HIV-Positive Patients
Related Studies:
Other Arthritis, Psoriatic Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis
|
|
|
|
|
|
|
|
