- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00796250
Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)
21. marts 2017 opdateret af: Merck Sharp & Dohme LLC
Efficacy of Infliximab as "Bridging Therapy" in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine
This is a double-blind, double-dummy, prednisolone-controlled, multi-center, randomized, parallel-group clinical study to evaluate the therapeutic efficacy of repeated infliximab infusions in order to maintain Crohn's disease remission at the end of the study.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
9
Fase
- Fase 3
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male and Female patients with age between 18 and 65 years.
- Patients suffering from corticodependent Crohn's disease, in reheightening phase, with CDAI value >=220.
- Patients able to participate and to comply with the study.
- Patients with adequate bone marrow stock: GB >=3.5x109/L, PLTs >=100 x 103, Hb >=9 gr/dL.
- Patients able and willing to give written informed consent.
Exclusion Criteria:
- Patients with abscesses or active perianal diseases.
- Clinically symptomatic and/or with retrodilatation intestinal stenosis.
- Patients previously treated with infliximab.
- Patients with history of allergy to murine proteins.
- Treatment with immunosuppressant such as AZA, 6-mercaptopurine, methotrexate and cyclosporine A during the previous 3 months.
- Positive feces exams for intestinal pathogens, parasitic or toxin of clostridium difficilis.
- Tuberculosis (TBC) both active and inactive, evaluated by means of a detailed description (personal history of tuberculosis or possible previous contact with a source of TBC infection), and appropriate screening tests, Thorax Rx, tuberculin test.
- Presence of severe infections such as hepatitis, pneumonia, pyelonephritis within the past 3 months before the enrolment. Less severe infections, such as those in charge of the upper respiratory tract (cold syndrome), are not considered exclusion criteria as well as the uncomplicated urinary tract infections, contracted during the previous 3 months before study inclusion.
- Ongoing infections due to CMV, pneumocystis carinii, atypical mycobacterium. Proved HIV infection, presence of ARC or AIDS.
- Necessity during the study of elective or emergency surgical operation.
- Altered hepatic function: total bilirubin >=1.5 times the upper limit of the normal ranges (UNL), AST (SGOT) >=2 UNL, phosphatase alkaline >=2.5 UNL, or PTT - INR >=1.5 UNL.
- Altered renal function: creatinine >=1.5 mg.
- Presence of serious concomitant illnesses (cardiac, pulmonary, neurological diseases).
- History of pathology in charge of the haemopoietic system and of lymphoproliferative diseases such as lymphoma, lymphadenopathies of unusual localisation (i.e. at the nape, epitochlear or periaortic) or splenomegaly.
- Presence of neoplastic or pre-neoplastic lesions, or history of neoplasm in the past 5 years.
- Presence or history of drug or alcohol abuse.
- Pregnant or lactating women.
- Women of childbearing potential without adequate contraception except in case of surgical menopause. These methods of birth control should also be used during the 6 months after the last infusion.
- Contraindications for AZA (i.e. lymphoproliferative diseases, leukopenia) and prednisolone (i.e. peptic ulcer, systemic fungal infections) as laid out in the summary of product characteristics.
- Hyperamylasemia >=1.5 times the upper limit of the normal ranges.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Gruppe A
|
Patients in this group were treated with azathioprine (AZA), infliximab, and placebo prednisolone.
Infliximab was to be administered at a dose of 5 mg/kg at Visit 2 (Week 0), and at Weeks 2, 6, and 14 (total of four infusions).
Infliximab infusions were administered by the investigators in the hospital during the patient's visit, usually in the morning.
Andre navne:
Patients in this group were treated with AZA, infliximab, and placebo prednisolone.
All patients were treated with AZA, by oral use, with a 2 mgkg dose a day until the end of the study (30 weeks).
Andre navne:
Patients in this group were treated with AZA, infliximab, and placebo prednisolone.
Placebo prednisolone was to be administered by oral use.
Andre navne:
Patients in this group were treated with AZA, prednisolone, and placebo infliximab.
All patients were treated with AZA, by oral use, with a 2 mgkg dose a day until the end of the study (30 weeks).
Andre navne:
|
Aktiv komparator: Gruppe B
|
Patients in this group were treated with AZA, infliximab, and placebo prednisolone.
All patients were treated with AZA, by oral use, with a 2 mgkg dose a day until the end of the study (30 weeks).
Andre navne:
Patients in this group were treated with AZA, prednisolone, and placebo infliximab.
All patients were treated with AZA, by oral use, with a 2 mgkg dose a day until the end of the study (30 weeks).
Andre navne:
Patients in this group were treated with AZA, prednisolone, and placebo infliximab.
Prednisolone was to be administered by oral use, with the decreasing dose of 40 mg a day, 35 mg a day, 30 mg a day and 25 mg a day every week for each dosage, respectively; 20 mg a day for five weeks; 15 mg a day, 10 mg a day and 5 mg a day for one week for each dosage respectively, until discontinuation.
Andre navne:
Patients in this group were treated with AZA, prednisolone, and placebo infliximab.
Placebo infliximab was to be administered at Visit 2 (Week 0), and at Weeks 2, 6, and 14 (total of four infusions).
Infliximab infusions were administered by the investigators in the hospital during the patient's visit, usually in the morning.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To evaluate the therapeutic efficacy of repeated infliximab infusions in order to maintain Crohn's disease remission (Crohn's disease Activity Index [CDAI] <=150) at the end of the study.
Tidsramme: Week 30
|
Week 30
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Tolerability evaluation (labs parameters, vital signs, adverse events).
Tidsramme: At each visit.
|
At each visit.
|
Quality of life assessment, by IBDQ questionnaire.
Tidsramme: Baseline, Week 10, and Week 30.
|
Baseline, Week 10, and Week 30.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2003
Primær færdiggørelse (Faktiske)
1. januar 2005
Studieafslutning (Faktiske)
1. januar 2005
Datoer for studieregistrering
Først indsendt
21. november 2008
Først indsendt, der opfyldte QC-kriterier
21. november 2008
Først opslået (Skøn)
24. november 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Gastroenteritis
- Tarmsygdomme
- Inflammatoriske tarmsygdomme
- Crohns sygdom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Neuroprotektive midler
- Beskyttelsesagenter
- Dermatologiske midler
- Prednisolon
- Methylprednisolonacetat
- Methylprednisolon
- Methylprednisolon Hemisuccinat
- Prednisolonacetat
- Prednisolon hemisuccinat
- Prednisolonfosfat
- Infliximab
- Azathioprin
Andre undersøgelses-id-numre
- P02732
Plan for individuelle deltagerdata (IPD)
Studiedata/dokumenter
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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-
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