Crohn DiseasePhase 3NCT00269841
An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease
A Phase 3 study testing Infliximab 10 mg/kg and Infliximab 5 mg/kg in people with Crohn Disease, run by Centocor, Inc..
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Infliximab 10 mg/kg and Infliximab 5 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- May 1996to Feb 1998
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Crohn's disease of at least 3 months duration confirmed by radiography orendoscopy
- Having single or multiple draining enterocutaneous (including perianal) fistulae of at least 3 months duration
- If treated with oral prednisone (or equivalent), the dose must be <=40 mg/day and must have been stable for at least 3 weeks prior to enrollment. (If currently not treated with oral prednisone, the stop date must have been at least 4 weeks prior to enrollment)
- If treated with 6-mercaptopurine or azathioprine, the start date must have been at least 6 months prior to enrollment. (The dose must have been stable for at least 8 weeks prior to enrollment. If currently not treated with 6-mercaptopurine or azathioprine, the stop date must have been at least 4 weeks prior to enrollment.)
Who cannot join
- Patients with local complications of Crohn's disease such as strictures or abscesses that might confound the evaluations of the benefit from cA2 treatment
- Having abscesses that should be drained prior to enrollment, with at least 3 weeks between drainage of the abscess and enrollment
- Having a serious infection, such as hepatitis, pneumonia or pyelonephritis, in the previous 3 months or a history of opportunistic infection such as herpes zoster within 2 months prior to screening, or evidence of active cytomegalovirus, active pneumocystis carinii, or drug resistant atypical mycobacterium
- Currently having signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease
- Currently having any known malignancy or any history of malignancy within the past 5 years
About this study
Official title: A Placebo-Controlled, Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease
The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease.
Read the detailed description
This is a randomized, placebo-controlled, double-blind, repeated-dose study to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease. The primary efficacy outcome of the study is the number of patients with at least a 50% reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits.
Patients will be treated with either anti-TNF chimeric monoclonal antibody (cA2) or matching placebo.
- Conditions
- Crohn Disease
- Being tested
- Infliximab 10 mg/kg, Infliximab 5 mg/kg, Placebo
- Keywords
- fistulae, Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab 10 mg/kgDrug
Also called anti-TNF chimeric monoclonal antibody (cA2)
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.
Infliximab 5 mg/kgDrug
Also called anti-TNF chimeric monoclonal antibody (cA2)
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.
PlaceboDrug
Matching placebo will be adminstered at Week 0, 2 and 6.
| Study group | Role | What they receive |
|---|---|---|
| Infliximab 10 mg/kg | Experimental | Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6. Receives: Drug: Infliximab 10 mg/kg |
| Infliximab 5 mg/kg | Experimental | Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6. Receives: Drug: Infliximab 5 mg/kg |
| Placebo | Placebo comparator | Matching placebo will be administered at Week 0, 2 and 6. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with 50% or more reduction from baseline in the number of open fistulae at Week 3
Number patients with 50% or more reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits that is not accompanied by initiation of a therapeutic agent or increase in dose.
Measured: Week 3
Secondary outcomes (1)
Percentage of patients achieving a complete response at week 52
The percentage of patients achieving a complete response; In patients responding to treatment, the median time to first observed reduction from baseline of 50% or greater in the number of open fistulae
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2005 (estimated)
- Study startMay 1996
- Primary completionFeb 1998
- Study completionFeb 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269841
- Sponsor's protocol ID
- CR006253
- Status last verified
- Nov 2014
- First submitted
- 22 Dec 2005
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999 May 6;340(18):1398-405. doi: 10.1056/NEJM199905063401804.
PubMed 10228190
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease
- ClinicalTrials.gov ID
- NCT00269841
- Acronym / sponsor ID
- CR006253
- Conditions
- Crohn Disease
- Keywords
- fistulae, Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- May 1996
- Primary completion
- Feb 1998 (actual)
- Study completion
- Feb 1998 (actual)
- First posted
- 26 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease.
Detailed description
This is a randomized, placebo-controlled, double-blind, repeated-dose study to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease. The primary efficacy outcome of the study is the number of patients with at least a 50% reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits.
Patients will be treated with either anti-TNF chimeric monoclonal antibody (cA2) or matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infliximab 10 mg/kg | Experimental | Drug: Infliximab 10 mg/kgInfliximab (anti-TNF chimeric monoclonal antibody [cA2]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6. |
| Infliximab 5 mg/kg | Experimental | Drug: Infliximab 5 mg/kgInfliximab (anti-TNF chimeric monoclonal antibody [cA2]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo will be administered at Week 0, 2 and 6. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with Crohn's disease of at least 3 months duration confirmed by radiography orendoscopy
- Having single or multiple draining enterocutaneous (including perianal) fistulae of at least 3 months duration
- If treated with oral prednisone (or equivalent), the dose must be <=40 mg/day and must have been stable for at least 3 weeks prior to enrollment. (If currently not treated with oral prednisone, the stop date must have been at least 4 weeks prior to enrollment)
- If treated with 6-mercaptopurine or azathioprine, the start date must have been at least 6 months prior to enrollment. (The dose must have been stable for at least 8 weeks prior to enrollment. If currently not treated with 6-mercaptopurine or azathioprine, the stop date must have been at least 4 weeks prior to enrollment.)
Key exclusion criteria (5 listed)
- Patients with local complications of Crohn's disease such as strictures or abscesses that might confound the evaluations of the benefit from cA2 treatment
- Having abscesses that should be drained prior to enrollment, with at least 3 weeks between drainage of the abscess and enrollment
- Having a serious infection, such as hepatitis, pneumonia or pyelonephritis, in the previous 3 months or a history of opportunistic infection such as herpes zoster within 2 months prior to screening, or evidence of active cytomegalovirus, active pneumocystis carinii, or drug resistant atypical mycobacterium
- Currently having signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease
- Currently having any known malignancy or any history of malignancy within the past 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infliximab 10 mg/kgAlso: anti-TNF chimeric monoclonal antibody (cA2)Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6. | Drug | Infliximab 10 mg/kg |
| Infliximab 5 mg/kgAlso: anti-TNF chimeric monoclonal antibody (cA2)Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6. | Drug | Infliximab 5 mg/kg |
| PlaceboMatching placebo will be adminstered at Week 0, 2 and 6. | Drug | Placebo |
Primary outcome
Number of patients with 50% or more reduction from baseline in the number of open fistulae at Week 3
Time frame: Week 3
Number patients with 50% or more reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits that is not accompanied by initiation of a therapeutic agent or increase in dose.
1 secondary outcome
Percentage of patients achieving a complete response at week 52
Time frame: Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
- Results publication: PubMed 10228190Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999 May 6;340(18):1398-405. doi: 10.1056/NEJM199905063401804.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centocor, Inc. Clinical Trial study director
Centocor, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infliximab 10 mg/kg and Infliximab 5 mg/kg in people with Crohn Disease, run by Centocor, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with 50% or more reduction from baseline in the number of open fistulae at Week 3 (time frame: Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00269841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2014.