- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00796250
Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)
21 mars 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
9
Fas
- Fas 3
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Grupp 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.
Andra namn:
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).
Andra namn:
Patients in this group were treated with AZA, infliximab, and placebo prednisolone.
Placebo prednisolone was to be administered by oral use.
Andra namn:
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).
Andra namn:
|
Aktiv komparator: Grupp 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).
Andra namn:
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).
Andra namn:
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.
Andra namn:
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
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.
Tidsram: Week 30
|
Week 30
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Tolerability evaluation (labs parameters, vital signs, adverse events).
Tidsram: At each visit.
|
At each visit.
|
Quality of life assessment, by IBDQ questionnaire.
Tidsram: Baseline, Week 10, and Week 30.
|
Baseline, Week 10, and Week 30.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 november 2003
Primärt slutförande (Faktisk)
1 januari 2005
Avslutad studie (Faktisk)
1 januari 2005
Studieregistreringsdatum
Först inskickad
21 november 2008
Först inskickad som uppfyllde QC-kriterierna
21 november 2008
Första postat (Uppskatta)
24 november 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 mars 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 mars 2017
Senast verifierad
1 mars 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Gastroenterit
- Tarmsjukdomar
- Inflammatoriska tarmsjukdomar
- Crohns sjukdom
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Antiinflammatoriska medel
- Antireumatiska medel
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Antiemetika
- Gastrointestinala medel
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Antineoplastiska medel, hormonella
- Neuroprotektiva medel
- Skyddsmedel
- Dermatologiska medel
- Prednisolon
- Metylprednisolonacetat
- Metylprednisolon
- Metylprednisolonhemisuccinat
- Prednisolonacetat
- Prednisolonhemisuccinat
- Prednisolonfosfat
- Infliximab
- Azatioprin
Andra studie-ID-nummer
- P02732
Plan för individuella deltagardata (IPD)
Studiedata/dokument
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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