Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease
monoclonal antibody cA2
Maladies du système digestif+7
+ Gastroentérite
+ Maladies intestinales
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 1996
Date à laquelle le premier participant a commencé l'étude.PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to investigational site and number of fistulae (single vs multiple). Patients are randomized to one of three treatment arms: Arm I: Patients receive an infusion of chimeric monoclonal antibody (cA2) on weeks 0, 2, and 6. Arm II: Patients receive an infusion of cA2 on weeks 0 and 2, and an infusion of placebo on week 6. Arm III: Patients receive an infusion of placebo on day 1 of weeks 0, 2, and 6. Patients are followed every month for 3 months, then every 6-12 months for up to 2 years.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.94 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 65 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Crohn's disease of at least 3 months duration confirmed by radiography or endoscopy Single or multiple draining enterocutaneous (including perianal) fistulae of at least 3 months duration All fistulae separate and distinctly identifiable No local complications of Crohn's disease such as strictures or abscesses --Prior/Concurrent Therapy-- Biologic therapy: No prior chimeric monoclonal antibody (cA2) At least 3 months since treatment with other therapeutic agent targeted at reducing tumor necrosis factor (e.g., pentoxifylline or thalidomide) At least 4 weeks since cyclosporine Chemotherapy: Concurrent methotrexate permitted if treatment began at least 3 months prior to enrollment, dose has been stable for at least 4 weeks prior to enrollment and remains stable throughout study period Otherwise, no methotrexate within 4 weeks prior to enrollment Concurrent 6-mercaptopurine or azathioprine permitted if treatment began at least 6 months prior to enrollment, dose has been stable for at least 8 weeks prior to enrollment, and remains stable throughout study period Otherwise, no 6-mercaptopurine or azathioprine within 4 weeks prior to enrollment Endocrine therapy: Concurrent corticosteroids (e.g., oral prednisone) permitted if dose has been stable for at least 3 weeks prior to enrollment, does not exceed 40 mg/kg, and remains stable throughout study period (dosage may be tapered after 6 weeks for some patients) Otherwise, no corticosteroids within 4 weeks prior to enrollment Other: Concurrent antibiotics or aminosalicylates for Crohn's disease permitted if dose has been stable for at least 4 weeks prior to enrollment and remains stable throughout study period Otherwise, no antibiotics or aminosalicylates within 4 weeks prior to enrollment At least 3 months since investigational drugs --Patient Characteristics-- Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Lymphocyte count at least 500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8.5 g/dL No severe, progressive, or uncontrolled hematologic disease Hepatic: SGOT no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN No severe, progressive, or uncontrolled hepatic disease Renal: Creatinine no greater than 1.7 mg/dL No severe, progressive, or uncontrolled renal disease Cardiovascular: No severe, progressive, or uncontrolled cardiac disease Pulmonary: No severe, progressive, or uncontrolled pulmonary disease Neurologic: No severe, progressive, or uncontrolled neurologic or cerebral disease Other: Negative pregnancy test required and no planned pregnancy within 7.5 months following first infusion Effective contraception required of fertile patients during and for 6 months after study No severe, progressive, or uncontrolled endocrine disease No serious infections (e.g., hepatitis, pneumonia, pyelonephritis) within prior 3 months No history of opportunistic infections (e.g., herpes zoster) within 2 months No allergy to murine proteins No active cytomegalovirus, Pneumocystis carinii, or drug resistant atypical mycobacterial infections No recent drug or alcohol abuse No HIV infection, ARC (AIDS-related complex) or AIDS Total parenteral nutrition or tube feeding not permitted No prior or concurrent malignancy within 5 years