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Phase II Trial using Infliximab in Subjects with Giant Cell Arteritis Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Phase II Trial using Infliximab in Subjects with Giant Cell Arteritis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase II Trial using Infliximab in Subjects with Giant Cell Arteritis Clinical research trials and Phase II Trial using Infliximab in Subjects with Giant Cell Arteritis medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Phase II Trial using Infliximab in Subjects with Giant Cell Arteritis. Phase II Trial using Infliximab in Subjects with Giant Cell Arteritis Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Phase II Trial using Infliximab in Subjects with Giant Cell Arteritis clinical trial. Participants frequently get the best healthcare available for their Phase II Trial using Infliximab in Subjects with Giant Cell Arteritis condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase II Trial using Infliximab in Subjects with Giant Cell Arteritis  Phase II Trial using Infliximab in Subjects with Giant Cell Arteritis
Phase II Trial using Infliximab in Subjects with Giant Cell Arteritis
For Condition: Giant Cell Arteritis,Granulomatous Arteritis
Status: Recruiting
Sponsor(s): Centocor , Cleveland Clinic Foundation Hospital,INSYSS
Synopsis: Phase II clinical trial looking for newly diagnosed subjects with giant cell arteritis (GCA) or temporal arteritis. Standard Infliximab care. Subjects may also have polymyalgia rheumatica (PMR).
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 50 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Have a diagnosis of GCA, according to ACR criteria for classification of GCA, by meeting 3 of 5 of the following criteria: • Age at disease onset 50 years. • New onset or new type of localized pain in the head. • Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries). • ESR of > 50 mm in the first hour by the Westergren method. • Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cell. - Have a diagnosis of GCA of 4 weeks’ duration. - Have an ESR 40 mm in the first hour by the Westergren method at the time of diagnosis of GCA. - Are receiving 40 mg/day of prednisone/prednisolone to maintain a normal ESR (< 40 mm in the first hour by Westergren method) and have no symptoms/signs of GCA. - For at least 1 week prior to randomization, are receiving a stable dose of 40 mg/day to 60 mg/day of prednisone/prednisolone, have a normal ESR, and have no symptoms/signs of GCA. - Women and men of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last study agent infusion. - Are considered eligible according to the TB eligibility assessment, screening, and early detection of reactivation rules. - Are able to adhere to the study visit schedule and understand and comply with other protocol requirements. - Are capable of giving informed consent, which must be obtained prior to any screening procedures. Exclusion Criteria: - Have a prior diagnosis of GCA > 4 weeks before screening or PMR that has been previously treated with GS, responded, and then relapsed. - Have failed to respond to glucocorticosteroid therapy within 5 days of initiation of therapy. - Have been able to maintain clinical remission on a dose of < 40 mg/day of prednisone/prednisolone. - Have received intravenous (IV) glucocorticosteroid therapy with an equivalent dose of > 1000 mg/day of methylprednisolone for > 3 days within the 4-week period prior to screening. - Have received immunosuppressive agents (e.g., methotrexate, azathioprine, hydroxychloroquine, mycophenolate mofetil, cyclophosphamide, chlorambucil, leflunomide) or IL-1 blocking agents (e.g., anakinra) within the 3-month period prior to screening. - Have received previous treatment with infliximab or other monoclonal antibodies within the 3-month period prior to screening. - Have had treatment with any other therapeutic agent targeted at reducing tumor necrosis factor (TNF) (e.g., pentoxifylline, thalidomide, etanercept, adalimumab) within the 3-month period prior to screening. - Have used any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer. - Have received any live virus or bacterial vaccinations within the 3 months before the first administration of the study agent or are expected to receive any live virus or bacterial vaccinations during the trial or up to 3 months after the last administration of the study agent. - Are participating or plan to participate in another investigative trial during participation in this trial. - Have had any previous adverse reactions or allergic reactions (e.g., anaphylaxis) associated with the administration of monoclonal antibodies or antibody fragments. - Have a known recent abuse or dependency (drug or alcohol [other than caffeine and/or nicotine]) within 3 years of screening. - Have screening tests that meet any of the following criteria: a. WBC count < 3500/mm3 b. Neutrophils < 1500/mm3 c. Hemoglobin < 8.5 g/dL d. Platelet count < 100,000/mm3 e. AST > 3 x upper limit of normal (ULN) f. Alkaline phosphatase > 3 x ULN - Have had serious infections (such as hepatitis, pneumonia, or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator. - Have had chronic or recurrent infectious disease including, but not limited to, chronic renal infection, chronic chest infection, (e.g., bronchiectasis), sinusitis, recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), open, draining or infected skin wound, or ulcer. - Are considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules. - Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, coccidioidomycosis, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening. - Have a chest x-ray at screening that shows evidence of malignancy, infection, or any abnormalities suggestive of TB. - Have documented current active hepatitis B or history of documented hepatitis C infection. - Have documented human immunodeficiency virus (HIV) infection. - Presence of a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening). - Have a known malignancy or history of malignancy within the 5-year period prior to screening (with the exception of squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence). - Have a history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, supraclavicular, epitrochlear, or periaortic areas), or splenomegaly. - Have a known history of demyelinating disease, such as multiple sclerosis or optic neuritis. - Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic,or cerebral disease. - Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter. - Have a known history of, or are currently on medications for, CHF. - Have poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.
Total Enrollment: 42
Location and Contact Information:
Harold Wood Hospital *Not yet recruiting*
Romford, Essex,
United Kingdom
Not yet recruiting Brenda Hughes 01708-708339
The Cleveland Clinic, Rheumatic & Immunologic Diseases *Not yet recruiting*
Cleveland, Ohio, 44195
United States
Not yet recruiting Debora Bork 216-445-8533
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Hyon Choi 617-726-2870
Rheumatology Division, Arcispedale S. Maria Nuova *Not yet recruiting*
Reggio Emilia, , 42100
Italy
Not yet recruiting Giuseppe Germano +39 0522 295905
Arizona Arthritis Research *Not yet recruiting*
Paradise Valley, Arizona, 85253
United States
Not yet recruiting Karen Lewandowski 480-443-8400
The Johns Hopkins Vasculitis Center *Not yet recruiting*
Baltimore, Maryland, 21224
United States
Not yet recruiting John Stone 410-550-6817
Winthrop University Hospital *Recruiting*
Mineola, New York, 11501
United States
Recruiting Lorraine Martone 516-663-3819
UZ Kuleuven *Not yet recruiting*
Leuven, , B-3000
Belgium
Not yet recruiting Rene Westhovens +32 16346341
Hospital Clinic, Internal Medicine *Not yet recruiting*
Barcelona, , 08036
Spain
Not yet recruiting Jose Hernandez-Rodriguez 34-93-2279365
Arthritis Treatment Center of South Bay *Recruiting*
Torrance, California, 90505
United States
Recruiting Kenneth Nies 310-373-0340
Mayo Clinic, Department of Rheumatology *Not yet recruiting*
Rochester, Minnesota, 55905
United States
Not yet recruiting Eric Matteson 507-284-8450
Will's Eye Hospital *Recruiting*
Philadelphia, Pennsylvania, 19146
United States
Recruiting Robert Sergott 215-893-2457
Erasme University Hospital, Department of Rheumatology *Not yet recruiting*
Brussels, , B-1070
Belgium
Not yet recruiting Serge Steinfeld +322 555 36 50
California Pacific Medical Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Lynne Day 415-600-3014
Addenbrooke's Hospital, Rheumatology Research Unit *Not yet recruiting*
Cambridge, , CB2 2QQ
United Kingdom
Not yet recruiting Sheila Smith 01223-2174-57
Arthritis, Rheumatic, and Back Disease Associates, PA *Not yet recruiting*
Voorhees, New Jersey, 08043
United States
Not yet recruiting Mary Whitener 856-424-5005
St. Luc University Hospital *Not yet recruiting*
Brussels, , B-1200
Belgium
Not yet recruiting Jean Devogelaer +32 2 764 5390
II Divisione di Medicina - Unita Reumatologica, Ospedale di Prato *Not yet recruiting*
Prato, , 59100
Italy
Not yet recruiting Laura Niccoli +39 0874 434572
Boston University School of Medicine, Arthritis Section *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Peter Merkel 617-638-4312
University of Wisconsin, Department of Medicine, Section of Rheumatology *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Carrie Otepka 608-265-4043
Additional Information:
Study ID Numbers: C0168T65; GCA
Study Start Date: October 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076726
Other Giant Cell Arteritis Studies:
1. Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases
2. Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis
3. Phase II Trial using Infliximab in Subjects with Giant Cell Arteritis
Related Studies:
Other Giant Cell Arteritis Clinical Trials
Other Clinical Trials
Other Cambridge Clinical Trials
Phase II Trial using Infliximab in Subjects with Giant Cell Arteritis
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