Crohn's DiseasePhase 4NCT00688636
Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery
A Phase 4 study testing infliximab in people with Crohn's Disease, run by University of Pittsburgh at 1 site in United States.
Trial summary
A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men/women > 18 years of age
- curative resection/ileocolonic anastomosis for Crohn's disease
- may have received previously received infliximab
- if on oral aminosalicylates or corticosteroids, dose must be stable for 4 weeks prior to surgery
- if on 6-mercaptopurine,azathioprine or methotrexate,individual must have been on it for minimum of 3 months prior to surgery with stable dose for 4 weeks
- men and women must use adequate birth control for duration of study and for 6 months after receiving the last infusion
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- antibiotics for treatment of Crohn's disease must be discontinued within 12 weeks after surgery; antibiotics are allowable throughout study as long as primary purpose of antibiotic therapy is not for primary treatment of Crohn's disease
- screening lab results must meet screening criteria (hemoglobin = or > 8.5g/dL; Serum glutamic oxaloacetic transaminase ,3 times upper normal limit,platelets =or> 100 x 10 9th/L; lymphocytes count =or> 0.5 x 10 9th/L and neutrophils =or> 1.0 x 10 9th/L
- have a documented negative reaction to a purified protein derivative skin test performed within 3 months prior to baseline
- have a normal chest radiograph results within 3 months prior to baseline
- are capable of providing written informed consent and obtained prior to conducting any protocol-specified procedures
- willing to adhere to the study visit schedule and other protocol requirements
- are considered eligible according to the tuberculosis eligibility assessment, screening and early detection of reactivation rules
- patients who undergo resective surgery and primary ileocolonic anastomosis with a temporary ileostomy upon takedown of the diverting ileostomy.
Who cannot join
- patients with greater than 10 years of Crohn's disease requiring first resection of a short (<10cm) fibrostenotic stricture
- macroscopically active disease at anastomosis at time of surgery
- presence of stoma
- prior severe infusion reaction to infliximab
- history of anaphylaxis to murine products or other chimeric proteins
- any of the following medications taken within 12 weeks of surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, investigational drugs, or medications targeted at reducing tumor necrosis factor
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- have a positive stool culture for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin and have clinically significant signs of an enteric infection at screening
- women who are pregnant, nursing or planning pregnancy during the trial or within 6 months after the last infusion
- patient with active tuberculosis, patient newly diagnosed with latent tuberculosis who's receiving tuberculosis prophylaxis, patient with recent close contact to individual with active tuberculosis
- have or have had opportunistic infection within 6 months of screening
- have chest radiograph within 3 months prior to screening that shows malignancy, infection, or abnormalities suggestive of tuberculosis
- documentation of seropositive for HIV
- documentation of a positive test for hepatitis B surface antigen or a history of documented hepatitis C
- have current signs/symptoms of systemic lupus erythematosus, or severe progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral diseases
- presence of a transplanted solid organ (with exception of corneal transplant > 3 months prior to randomization)
- Have any current or known malignancy or have history of malignancy within 5 years of screening(except for squamous or basal cell carcinoma of the skin that has been fully excised with no evidence of recurrence)
- have history of lymphoproliferative disease or splenomegaly
- have known substance abuse(drug/alcohol)/dependency within the previous 3 years, history of noncompliance with medical regimens, or other condition that may interfere with adherence to protocol requirements
- are unwilling/unable to undergo multiple venipunctures because of poor tolerability or lack of easy access
- known history of demyelinating disease
- a chronic or recurrent infectious disease
- serious infection, hospitalization for infection, or treatment with IV antibiotics for infection within 2 months prior to randomization
- a serious concomitant illness that may interfere with participation in trial
- concomitant diagnosis/history of congestive heart failure
- current use of prescription doses or chronic/frequent use of non-steroidal anti-inflammatory drugs
- ulcerative colitis
- concurrent participation in another investigative trial
- use of any investigational drug within 30 days prior to randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo
- Conditions
- Crohn's Disease
- Being tested
- infliximab, placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infliximabDrug
Also called Remicade
5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
placeboDrug
placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: infliximab |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year
Endoscopic recurrence was defined as i2,i3,i4. We used the Rutgeerts' Endoscopic Scoring System. Scores as follows i0, no lesions; i1, 5 or fewer aphthous lesions; i2, more than 5 aphthous lesions with normal mucosa between the lesions or skip areas of larger lesions or lesions confined to the ileocolonic anastomosis; i3, diffuse, aphthous ileitis with diffusely inflamed mucosa; and i4, diffuse inflammation with large ulcers, nodules, and/or narrowing. Endoscopic recurrence was defined as i2,i3,i4 and endoscopic remission was defined as i0 or i1.
Measured: one year
Secondary outcomes (4)
Clinical Recurrence at One Year: Defined by Crohn's Disease Activity Index (CDAI) > 200
The Crohn's Disease Activity Index (CDAI) is calculated by a measurement of symptoms, signs, and lab tests over a time period of the previous 7 days. The CDAI includes: Number of very soft stools; sum of abdominal pain ratings: (0=none, 1= mild, 2=moderate, 3=severe); general well being (0=well, 1=slightly below par, 2=poor, 3=very poor, 4=terrible); Symptoms or findings presumed related to Crohn's disease (present): arthritis or arthralgia, iritis or uveitis, erythema nodosum, pyoderma gangrenosum, aphthous stomatitis, anal fissure, fistula or perirectal abscess, other bowel related fistula, febrile episode over 100 degrees during past week, taking lomotil or opiates for diarrhea, abnormal mass (0=none; 0.4=questionable; 1=present) hematocrit [(typical-current) X 6] Normal average male = 47, female =42, body weight
Measured: One year
Histological Recurrence of Crohn's Disease as Determined From Biopsies of Neo-terminal Ileum Above the Ileocolonic Anastomosis
Histologic recurrence based on a histologic activity score and the presence of polymononuclear cells. The maximum score is 14 per biopsy site.
Measured: One year
C-reactive Protein Concentration as a Surrogate Marker of Inflammation
The CRP was obtained at each study visit as a surrogate marker of inflammation. The CRP was recorded as milligram per deciliter (mg/dl). A normal CRP was 0-0.8 mg/dl; levels exceeding 0.8 mg/dl indicated inflammation.
Measured: one year
Mean Erythrocyte Sedimentation Rate
erythrocyte sedimentation rate value - blood test
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startJan 2005
- Primary completionAug 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor, Inc.
- Responsible party
- Principal investigator, Miguel Regueiro, University of Pittsburgh
- Investigators
- Miguel D Regueiro, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688636
- Sponsor's protocol ID
- C0168X75
- Status last verified
- Sep 2016
- First submitted
- 29 May 2008
- Last updated
- 26 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Regueiro M, Schraut W, Baidoo L, Kip KE, Sepulveda AR, Pesci M, Harrison J, Plevy SE. Infliximab prevents Crohn's disease recurrence after ileal resection. Gastroenterology. 2009 Feb;136(2):441-50.e1; quiz 716. doi: 10.1053/j.gastro.2008.10.051. Epub 2008 Oct 31.
PubMed 19109962
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery
- ClinicalTrials.gov ID
- NCT00688636
- Acronym / sponsor ID
- C0168X75
- Conditions
- Crohn's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Centocor, Inc.
- Study start
- Jan 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Posted 26 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: infliximab |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- men/women > 18 years of age
- curative resection/ileocolonic anastomosis for Crohn's disease
- may have received previously received infliximab
- if on oral aminosalicylates or corticosteroids, dose must be stable for 4 weeks prior to surgery
- if on 6-mercaptopurine,azathioprine or methotrexate,individual must have been on it for minimum of 3 months prior to surgery with stable dose for 4 weeks
Key exclusion criteria (28 listed)
- patients with greater than 10 years of Crohn's disease requiring first resection of a short (<10cm) fibrostenotic stricture
- macroscopically active disease at anastomosis at time of surgery
- presence of stoma
- prior severe infusion reaction to infliximab
- history of anaphylaxis to murine products or other chimeric proteins
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 |
|---|---|---|
| infliximabAlso: Remicade5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6 | Drug | 1 |
| placeboplacebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6 | Drug | 2 |
Primary outcome
Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year
Time frame: one year
Endoscopic recurrence was defined as i2,i3,i4. We used the Rutgeerts' Endoscopic Scoring System. Scores as follows i0, no lesions; i1, 5 or fewer aphthous lesions; i2, more than 5 aphthous lesions with normal mucosa between the lesions or skip areas of larger lesions or lesions confined to the ileocolonic anastomosis; i3, diffuse, aphthous ileitis with diffusely inflamed mucosa; and i4, diffuse inflammation with large ulcers, nodules, and/or narrowing. Endoscopic recurrence was defined as i2,i3,i4 and endoscopic remission was defined as i0 or i1.
4 secondary outcomes
Clinical Recurrence at One Year: Defined by Crohn's Disease Activity Index (CDAI) > 200
Time frame: One year
Histological Recurrence of Crohn's Disease as Determined From Biopsies of Neo-terminal Ileum Above the Ileocolonic Anastomosis
Time frame: One year
C-reactive Protein Concentration as a Surrogate Marker of Inflammation
Time frame: one year
Mean Erythrocyte Sedimentation Rate
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19109962Regueiro M, Schraut W, Baidoo L, Kip KE, Sepulveda AR, Pesci M, Harrison J, Plevy SE. Infliximab prevents Crohn's disease recurrence after ileal resection. Gastroenterology. 2009 Feb;136(2):441-50.e1; quiz 716. doi: 10.1053/j.gastro.2008.10.051. Epub 2008 Oct 31.
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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.
Miguel D Regueiro, M.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing infliximab in people with Crohn's Disease, run by University of Pittsburgh at 1 site in United States.
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 14 inclusion and 28 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 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year (time frame: one year). 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 NCT00688636, 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 26 Sep 2016.