Crohn DiseasePhase 2/3NCT00269854
An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's Disease
A Phase 2/3 study testing Infliximab 5 mg/kg, Infliximab 10 mg/kg and Infliximab 20 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 patients with active 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 5 mg/kg, Infliximab 10 mg/kg and Infliximab 20 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jun 1995to Oct 1996
- Phase
- Phase 2/3
- 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 6 months duration, with colitis, ileitis, or ileocolitis confirmed by radiography or endoscopy
- Having a Crohn's Disease Activity Index (CDAI) of >=220 and <=400
- Treated with at least 1 of the following: current use of oral corticosteroid therapy of <=40 mg/day (prednisone equivalent), current use of (or lack of response to) >=2 g/day of sulfasalazine (or equivalent) or >=800 mg of mesalamine, current use of (or lack of response to) azathioprine or 6-mercaptopurine, failure to respond to methotrexate or cyclosporine, (with a stop date at least 3 months prior to screening)
- If using oral corticosteroids, sulfasalazine or mesalamine, a start date at least 8 weeks prior to screening, with a stable dose of sulfasalazine or mesalamine for at least 4 weeks prior to screening and a stable dose of oral corticosteroids for at least 2 weeks prior to screening
- If not currently using oral corticosteroids, a stop date of any previous corticosteroid regimen of at least 4 weeks prior to screening and if not using sulfasalazine, mesalamine, azathioprine or 6-mercaptopurine, a stop date of any previous treatment with these agents of at least 8 weeks prior to screening
Who cannot join
- Patients with Crohn's disease limited to the stomach or proximal small intestine
- Having symptomatic stenosis or ileal strictures that might have require surgical intervention or that might render patients unresponsive to cA2 treatment
- Who have received treatment with parenteral corticosteroid or adrenocorticotrophic hormone within 4 weeks prior to screening, or currently requiring oral or parenteral corticosteroid therapy for another disease such as asthma
- Having a serious infection, such as hepatitis, pneumonia or pyelonephritis in the 3 months prior to screening, 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
- Having active signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease, or any current known malignancy or any history of malignancy which would put the patient at an unacceptable risk for participation in the study or that would be expected to limit life expectancy
About this study
Official title: A Placebo-Controlled, Dose-Ranging Study Followed by a Placebo-Controlled, Repeated-Dose Extension of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Active 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 patients with active Crohn's disease.
Read the detailed description
This is a randomized, placebo-controlled, double-blind, dose-ranging study followed by a placebo-controlled, double-blind, repeated-dose extension to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with active Crohn's disease. The primary efficacy outcome of the study is a comparison of the proportion of patients achieving a clinical response at the 4-week evaluation. Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 70 points. Additional measurements of effectiveness include the clinical response over time, the time to loss of response, clinical remission over time, and changes in the Crohn's Disease Activity Index (CDAI), Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn's Disease Endoscopic Index of Severity (CDEIS) scores and C-reactive protein values.
Anti-TNF Chimeric Monoclonal Antibody (cA2) or placebo
- Conditions
- Crohn Disease
- Being tested
- Infliximab 5 mg/kg, Infliximab 10 mg/kg, Infliximab 20 mg/kg, Placebo
- Keywords
- 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 5 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 10 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.
Infliximab 20 mg/kgDrug
Also called anti-TNF chimeric monoclonal antibody (cA2)
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 20 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 5 mg/kg | Experimental | Not described Receives: Drug: Infliximab 5 mg/kg |
| Infliximab 10 mg/kg | Experimental | Not described Receives: Drug: Infliximab 10 mg/kg |
| Infliximab 20 mg/kg | Experimental | Not described Receives: Drug: Infliximab 20 mg/kg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportion of patients achieving a clinical response at Week 4
Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 70 points.
Measured: Week 4
Secondary outcomes (1)
Clinical response over time; Time to loss of response; Clinical remission over time; Changes in CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ) and Crohn's Disease Endoscopic Index of Severity (CDEIS) scores and C-reactive protein values
Measured: up to Week 48
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 startJun 1995
- Primary completionOct 1996
- Study completionOct 1996
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 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
- NCT00269854
- Sponsor's protocol ID
- CR006256
- Status last verified
- Nov 2014
- First submitted
- 22 Dec 2005
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Targan SR, Hanauer SB, van Deventer SJ, Mayer L, Present DH, Braakman T, DeWoody KL, Schaible TF, Rutgeerts PJ. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. N Engl J Med. 1997 Oct 9;337(15):1029-35. doi: 10.1056/NEJM199710093371502.
PubMed 9321530
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, Dose-Ranging Study Followed by a Placebo-Controlled, Repeated-Dose Extension of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT00269854
- Acronym / sponsor ID
- CR006256
- Conditions
- Crohn Disease
- Keywords
- Crohn's Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 1995
- Primary completion
- Oct 1996 (actual)
- Study completion
- Oct 1996 (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 patients with active Crohn's disease.
Detailed description
This is a randomized, placebo-controlled, double-blind, dose-ranging study followed by a placebo-controlled, double-blind, repeated-dose extension to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with active Crohn's disease. The primary efficacy outcome of the study is a comparison of the proportion of patients achieving a clinical response at the 4-week evaluation. Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 70 points. Additional measurements of effectiveness include the clinical response over time, the time to loss of response, clinical remission over time, and changes in the Crohn's Disease Activity Index (CDAI), Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn's Disease Endoscopic Index of Severity (CDEIS) scores and C-reactive protein values.
Anti-TNF Chimeric Monoclonal Antibody (cA2) or placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Infliximab 5 mg/kg | Experimental | Drug: Infliximab 5 mg/kg |
| Infliximab 10 mg/kg | Experimental | Drug: Infliximab 10 mg/kg |
| Infliximab 20 mg/kg | Experimental | Drug: Infliximab 20 mg/kg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Crohn's disease of at least 6 months duration, with colitis, ileitis, or ileocolitis confirmed by radiography or endoscopy
- Having a Crohn's Disease Activity Index (CDAI) of >=220 and <=400
- Treated with at least 1 of the following: current use of oral corticosteroid therapy of <=40 mg/day (prednisone equivalent), current use of (or lack of response to) >=2 g/day of sulfasalazine (or equivalent) or >=800 mg of mesalamine, current use of (or lack of response to) azathioprine or 6-mercaptopurine, failure to respond to methotrexate or cyclosporine, (with a stop date at least 3 months prior to screening)
- If using oral corticosteroids, sulfasalazine or mesalamine, a start date at least 8 weeks prior to screening, with a stable dose of sulfasalazine or mesalamine for at least 4 weeks prior to screening and a stable dose of oral corticosteroids for at least 2 weeks prior to screening
- If not currently using oral corticosteroids, a stop date of any previous corticosteroid regimen of at least 4 weeks prior to screening and if not using sulfasalazine, mesalamine, azathioprine or 6-mercaptopurine, a stop date of any previous treatment with these agents of at least 8 weeks prior to screening
Key exclusion criteria (5 listed)
- Patients with Crohn's disease limited to the stomach or proximal small intestine
- Having symptomatic stenosis or ileal strictures that might have require surgical intervention or that might render patients unresponsive to cA2 treatment
- Who have received treatment with parenteral corticosteroid or adrenocorticotrophic hormone within 4 weeks prior to screening, or currently requiring oral or parenteral corticosteroid therapy for another disease such as asthma
- Having a serious infection, such as hepatitis, pneumonia or pyelonephritis in the 3 months prior to screening, 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
- Having active signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease, or any current known malignancy or any history of malignancy which would put the patient at an unacceptable risk for participation in the study or that would be expected to limit life expectancy
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 5 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 5 mg/kg |
| Infliximab 10 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 10 mg/kg |
| Infliximab 20 mg/kgAlso: anti-TNF chimeric monoclonal antibody (cA2)Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 20 mg/kg will be administered as infusion at Week 0, 2 and 6. | Drug | Infliximab 20 mg/kg |
| PlaceboMatching placebo will be adminstered at Week 0, 2 and 6. | Drug | Placebo |
Primary outcome
Comparison of the proportion of patients achieving a clinical response at Week 4
Time frame: Week 4
Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 70 points.
1 secondary outcome
Clinical response over time; Time to loss of response; Clinical remission over time; Changes in CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ) and Crohn's Disease Endoscopic Index of Severity (CDEIS) scores and C-reactive protein values
Time frame: up to Week 48
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 9321530Targan SR, Hanauer SB, van Deventer SJ, Mayer L, Present DH, Braakman T, DeWoody KL, Schaible TF, Rutgeerts PJ. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. N Engl J Med. 1997 Oct 9;337(15):1029-35. doi: 10.1056/NEJM199710093371502.
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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 2/3 study testing Infliximab 5 mg/kg, Infliximab 10 mg/kg and Infliximab 20 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 5 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Comparison of the proportion of patients achieving a clinical response at Week 4 (time frame: Week 4). 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 NCT00269854, 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.