Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)

NCT00796250 | Terminated Phase 3

• 1 other identifier: P02732
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 30

Secondary Outcomes (2)

• Tolerability evaluation (labs parameters, vital signs, adverse events).

  At each visit.

• Quality of life assessment, by IBDQ questionnaire.

  Baseline, Week 10, and Week 30.

Study Arms (2)

Group A

EXPERIMENTAL

Biological: Infliximab; Drug: AZA; Drug: Placebo Prednisolone

Group B

ACTIVE COMPARATOR

Drug: Prednisolone; Drug: AZA; Biological: Placebo Infliximab

Interventions

Infliximab BIOLOGICAL

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.

Also known as: Remicade, SCH 215596

Group A

AZA DRUG

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).

Also known as: Imuran

Group A

Placebo Prednisolone DRUG

Patients in this group were treated with AZA, infliximab, and placebo prednisolone. Placebo prednisolone was to be administered by oral use.

Also known as: Placebo

Group A

Prednisolone DRUG

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.

Also known as: Pediapred

Group B

Placebo Infliximab BIOLOGICAL

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.

Also known as: Placebo

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Leombruno JP, Nguyen GC, Grootendorst P, Juurlink D, Einarson T. Hospitalization and surgical rates in patients with Crohn's disease treated with infliximab: a matched analysis. Pharmacoepidemiol Drug Saf. 2011 Aug;20(8):838-48. doi: 10.1002/pds.2132. Epub 2011 Jun 17.

  PMID: 21688345 RESULT

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab; Azathioprine; Prednisolone; prednisolone phosphate

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: November 1, 2003
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: March 23, 2017

Record last verified: 2017-03