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Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis Clinical research trials and Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis. Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis clinical trial. Subjects typically recieve the finest healthcare available for their Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis  Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis
Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis
For Condition: Psoriasis
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Several studies have documented an essential role for interleukin-10 (IL-10) in preventing prolonged and exaggerated immune responses to antigens and irritants. Psoriasis, a relatively common disease, is characterized by T cell-mediated inflammation in affected skin. In this study, the safety, tolerance, immunologic effects, and clinical activity of subcutaneous (SC) recombinant human (rh) IL-10 will be evaluated in patients with moderate-to-severe psoriasis. There will be 2 groups of patients, randomized to receive either 20 ug/kg rhIL-10 SC 3 times weekly (20 patients) or SC placebo (10 patients). This double-blind phase will continue for a total of 12 weeks and the principal evaluation will be the comparison between baseline and 12 week Psoriasis Area Severity Index (PASI) scores. Patients will come for an initial screening visit at day 0, and at weeks 1, 2, 4, 6, 8, and 12, with follow-up visits at weeks 16 and 20. All patients will be offered rhIL-10 at 12 weeks (following the blinded portion of the study protocol). Patients initially receiving active medication who wish to continue rhIL-10 therapy will be kept on the drug. This open-label portion of the study will continue for an additional 12 weeks. Patients continuing with active drug will be evaluated at weeks 14, 16, 20, and 24. Skin disease activity and toxicity will be assessed and recorded throughout the study. In addition, research studies will include functional assays to assess cytokine secretion and immunologic function of peripheral blood cells and immunohistochemical characterization of the inflammatory cells in skin.
Details: Several studies have documented an essential role for interleukin-10 (IL-10) in preventing prolonged and exaggerated immune responses to antigens and irritants. Psoriasis, a relatively common disease, is characterized by T cell-mediated inflammation in affected skin. In this study, the safety, tolerance, immunologic effects, and clinical activity of subcutaneous (SC) recombinant human (rh) IL-10 will be evaluated in patients with moderate-to-severe psoriasis. There will be 2 groups of patients, randomized to receive either 20 (micro)g/kg rhIL-10 SC 3 times weekly (20 patients) or SC placebo (10 patients). This double-blind phase will continue for a total of 12 weeks and the principal evaluation will be the comparison between baseline and 12 week Psoriasis Area Severity Index (PASI) scores. Patients will come for an initial screening visit at day 0, and at weeks 1, 2, 4, 6, 8, and 12, with follow-up visits at weeks 16 and 20. All patients will be offered rhIL-10 at 12 weeks (following the blinded portion of the study protocol). Patients initially receiving active medication who wish to continue rhIL-10 therapy will be kept on the drug. This open-label portion of the study will continue for up to an additional 12 weeks. Patients continuing with active drug will be evaluated at weeks 14, 16, 20, and 24. Skin disease activity and toxicity will be assessed and recorded throughout the study. In addition, research studies will include functional assays to assess cytokine secretion and immunologic function of peripheral blood cells and immunohistochemical characterization of the inflammatory cells in skin.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Able to provide informed consent to all aspects of the study after full information is provided. Age equal to or between 18 and 65 years. Moderate-to-severe stable plaque psoriasis of at least 6 months duration as defined by the following criteria: 1) Classic psoriatic skin lesions with or without nail involvement, 2) Psoriasis Area and Severity Index score greater than 10(i), 3) Total body surface area involved greater than 10%. Weight less than 242 pounds. Must be able to self-administer medication (subcutaneous injection) or arrange for administration. No unstable psoriatic disease, including erythrodermic, pustular, and palmar/plantar variants. No use of topical medications for psoriasis (except for bland emollients) during 2 weeks prior to study entry. No use of systemic medications for psoriasis during 1 month prior to study entry. No patients with an ECOG or Zubrod Performance Status Scale greater than 2. No patients with acute or chronic infections requiring antimicrobial therapy or serious viral (e.g., hepatitis, herpes zoster, or HIV) or fungal infections as the effects of IL-10 on the immune system not completely elucidated and treatment could pose additional risk to the patient. Patients with a positive PPD who have not received antituberculous therapy may be excluded, if in the opinion of an infectious consultant, IL-10 treatment is contraindicated. No patients receiving disease modifying anti-inflammatory drugs (methotrexate, sulfasalazine, gold, hydroxychloroquine, cyclosporin, azathioprine, cyclophosphamide, chlorambucil, retinoids, vitamin D). Such drugs will be discontinued at least 4 weeks prior to randomization. No pregnant females, nursing mothers, or patients of childbearing age not practicing birth control, since the risks to the unborn fetus and newborn child are unknown. No previous history of malignancy or current malignancy other than satisfactorily treated basal-squamous cell carcinoma or in situ cervical carcinoma. No confounding medical illness that in the judgment of the investigators would pose added risk for study participants (e.g., hepatic, hematologic [e.g., hematocrit less than or equal to 28% or platelet counts less than 100,000/ml], neurologic, renal, or pulmonary disease). No patients with serum creatinine greater than 1.8 or creatinine clearance (CrCl) less than 50 ml/min. No patients with abnormal liver function tests (e.g., serum glumatic oxalacetic transaminase, serum glutamic pyruvic transaminase or alkaline phosphatase levels greater than 2.5x upper limit of normal (UNL) and/or bilirubin levels 1.5x UNL). No current alcohol or drug abuse.
Total Enrollment: 36
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990027; 99-C-0027
Study Start Date: January 12, 1999
Record last reviewed: December 1, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001797
Other Psoriasis Studies:
1. To study the effects of CD25 and low dose Cyclosporin in the treatment of active Psoriasis vulgaris
2. Study of Psoriatic Arthritis
3. A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis
4. Assessment of Digital Imaging as a Tool for Diagnosing Psoriasis, Hand Rashes and Unusual Moles
5. Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis
Related Studies:
Other Psoriasis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Randomized Double-Blind Placebo-Controlled Trial Using Recombinant Human Interleukin-10 for Moderate-to-Severe Psoriasis
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