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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00752622
Date of registration: 12/09/2008
Prospective Registration: Yes
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: Treatment With Infliximab in a Medical Setting (Study P05587) OPTIMIST
Scientific title: Optimization of Treatment With Infliximab in a Medical Setting
Date of first enrolment: November 2008
Target sample size: 100
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT00752622
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Canada
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Men and women >=18 years of age

- Moderate to severe CD (Crohn's Disease Activity Index [CDAI] >= 220 and <= 450)

- CD of at least 3 months duration confirmed within the past 2 years by radiography
and/or endoscopy

- Biologic-naïve

- If using 5-Aminosalicylic Acid (5-ASA), there must be at least 4 weeks of stable
dosage prior to screening

- If using azathioprine or 6-mercaptopurine, the start date must be at least 3 months
prior to screening and the dose must be stable for at least 6 weeks prior to screening

- If using methotrexate, the participant must have been using methotrexate with a stable
dosage of at least 6 weeks prior to screening

- Participants must be off corticosteroids or on a stable dose of corticosteroids for at
least 2 weeks prior to enrollment. The maximal daily dose of corticosteroids at
baseline must not exceed 30 mg of prednisone equivalent

- Participants are considered eligible according to the following tuberculosis (TB)
screening criteria:

- Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination

- Have had no recent close contact with a person with active TB or, if there has
been such contact, will be referred to a physician specializing in TB to undergo
additional evaluation and, if warranted, receive appropriate treatment for latent
TB prior to or simultaneously with the first administration of study medication

- Within 3 months prior to the first administration of study medication, either
have negative OR have a newly identified positive diagnostic TB test result
(defined as at least 1 positive tuberculin skin test) during screening in which
active TB has been ruled out, and for which appropriate treatment for latent TB
has been initiated either prior to or simultaneously with the first
administration of study medication

- Participants must have had a chest X-ray within 3 months prior to screening with
no evidence of current or old active TB

- Participants' screening and baseline clinical laboratory tests (complete blood count
[CBC], blood chemistries, and urinalysis) must be within the following parameters:

- Hemoglobin >=10 g/dL (100 g/L)

- White blood cells (WBCs) >=3.5 x 109/L

- Neutrophils >=1.5 x 10^9/L

- Platelets >=100 x 10^9/L

- Serum creatinine <1.5 mg/dL (or <133 µmol/L)

- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline
phosphatase, and gammaglutamyltransferase <=1.5 x upper limit of normal (ULN);

- Total bilirubin <=1 x ULN

- Antibiotics for the treatment of CD (e.g., ciprofloxacin and metronidazole) must have
been discontinued at least 3 weeks prior to screening

- Participants must be free of any clinically significant condition or situation, other
than CD that, in the opinion of the investigator, would interfere with the study
evaluations or optimal participation in the study

- Participants are willing and able to adhere to the study visit schedule and other
protocol requirements

- Participants are capable of providing written informed consent, which must be obtained
prior to conducting any protocol-specified procedures

- Sexually-active women of child-bearing potential must agree to use a medically
accepted method of contraception prior to screening, while receiving protocol
specified medication, and for 6 months after stopping the medication

- Women of child-bearing potential who are not currently sexually active must agree to
use a medically accepted method of contraception should they become sexually active
while participating in the study

- Female participants of childbearing potential must have a negative serum pregnancy
test (beta-hCG) at screening

- have an increased Harvey-Bradshaw Index (HBI) score >=3 points over the week 10
evaluation score and a CDAI score >=175

- have received regular infusions of Infliximab (IFX) every 8 weeks during the
observational phase with a maximum interval of no more than 10 weeks between each
infusions

- having previous doses of IFX of >= 4.7 mg/kg

Exclusion Criteria:

- Are pregnant or plan to become pregnant during the study period; participants who are
breast feeding

- Have been treated with excluded drugs prior to entry: any biological or anti- Tumor
necrosis factor (anti-TNF) agent such as infliximab, adalimumab, certolizumab,
etanercept, pentoxifylline, or thalidomide

- Have had a serious infectious disease in the 8 weeks prior to entry

- Have active perianal fistulas and a Perianal disease activity index (PDAI) score >10

- Have presumed fibro-stenotic stricture or acute bowel obstruction

- Have had live vaccination in the 6 weeks prior to entry

- Have known intolerance to study drug

- Have a history of myocardial infarction, congestive heart failure, coronary artery
disease, or arrhythmias in the last 6 months

- Have a history of malignancy (within the past 5 years) with the exception of carcinoma
in situ of the cervix or localized basal cell skin cancer that have been adequately
treated

- Have a history of lymphoproliferative disease including lymphoma, or signs and
symptoms suggestive of possible lymphoproliferative disease

- Have a history of demyelinating disease such as multiple sclerosis

- Have a positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV)
surface antigen, or hepatitis C virus (HCV) antibody

- Have renal, hepatic, hematological, cardiovascular, pulmonary, neurological,
psychiatric, immunologic, gastrointestinal, endocrine, or other diseases if they are
clinically significant. (A clinically significant disease is defined as one which in
the opinion of the investigator can put the participants at risk because of
participation in the study or a disease which can influence the participant's ability
to participate in the study or affect the results of the

study)

- Have clinically significant abnormal laboratory test results, unless regarded by the
investigator as related to CD

- Have a history of alcohol or drug abuse

- Are unable to comply with the protocol

- Have any clinically significant findings in the physical examination that, in the
investigator's ju



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Biological: Infliximab 5 mg/kg
Biological: Infliximab 5 mg/kg every 6 weeks
Biological: Infliximab 7 mg/kg every 8 weeks
Primary Outcome(s)
Mean Change From Baseline in Harvey-Bradshaw Index (HBI) [Time Frame: Baseline and Evaluation Week 10, Week 30 and Week 54 of the Observational Phase]
Number of Participants Who Had a Clinical Response Using the Crohn's Disease Activity Index (CDAI) at Week 24 in the Interventional Phase [Time Frame: Baseline and Week 24 of the Interventional phase]
Secondary Outcome(s)
Number of Participants That Required Treatment Optimization in the Observational Phase [Time Frame: Week 54 in the Observational Phase]
Number of Participants Who Had a Clinical Response Using the CDAI at Weeks 14-16 and 48 in the Interventional Phase [Time Frame: Baseline and Weeks 14-16 and 48 in the Interventional Phase]
Number of Participants Who Had a Clinical Response Using the CDAI-100 at Weeks 14-16, 24 and 48 in the Interventional Phase [Time Frame: Baseline and Weeks 14-16, 24 and 48 in the Interventional Phase]
Number of Participants Who Had Clinical Remission in the Interventional Phase [Time Frame: Weeks 14-16, 24 and 48 in the Interventional Phase]
Number of Participants Who Had Clinical Remission Off Steroids in the Interventional Phase [Time Frame: Weeks 14-16, 24 and 48 in the Interventional Phase]
Secondary ID(s)
P05587
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 22/07/2011
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00752622
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