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Crohn DiseasePhase 3POPARTNCT01629628

Adalimumab for the Management of Post-operative Crohn's Disease (CD)

A Phase 3 study testing Adalimumab and 6 Mercaptopurine in people with Crohn Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will be a prospective, open label, randomized, comparative study. Comparing the efficacy of adalimumab with immunomodulator therapy (i.e. 6-mercaptopurine, 6-MP), in maintaining remission of post-operative CD patients, with a high risk of disease recurrence. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Crohn Disease
What is being tested?
Adalimumab and 6 Mercaptopurine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteIsrael
Study dates
Jul 2012to Jul 2016
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-70 years old at the time of screening
  • Male or female
  • Firs ileocolonic surgical resection (
  • Evidence of both macroscopic as well an microscopic evidence of Crohn's disease in the resected intestinal segment
  • Patient able to undergo pre randomization screening no earlier then 14 days and no later then 45 days post operatively.
  • Patients may receive anti-TNF-agents (i.g. infliximab or adalimumab)previously
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  • Patients may receive corticosteroids, 6MP/AZA, methotrexate, or mesalamine prior to surgery.
  • Antibiotics, or mesalamine, must be discontinued within the screening/baseline 4 week period. Patients on steroids may be enrolled as long as steroids are tapered off.
  • Remission as defined by a CDAI ≤ 150.
  • Women of childbearing potential, and men, must use medically acceptable methods of contraception [surgical sterilization, IUD, hormonal preparations, or double barrier method (e.g. condom or diaphragm, and spermicide)] throughout the study and for a period of 6 months after receiving the last injection.
  • Screening lab results must be within prespecified limits: Hemoglobin ≥ 8.8 g/dl; SGOT/SGPT < 3 X the upper limit of normal; Neutrophil count ≥ 1.0 X 109/L \& lymphocyte cont of ≥ 0.5 X 109/L
  • Must have a documented PPD ≤ 5 mm, in patients taking steroids, within the month before randomization, or taking immunomodulators 2 months prior to randomization. Other patients must have documented PPD ≤ 10 mm prior to randomization. PPD must be preformed and documented by an appointed member of the investigatory stuff. Patients must have a normal chest radiograph (both posterior-anterior and lateral views), read by a certified radiologist, within 3 months prior to randomization.
  • Commitment to adhere to study protocol requirements
  • Negative stool cultures for enteric pathogens (Salmonella, Shigella, Campylobacter, Ova \& parasites), and negative clostridium difficile toxin assay in stool.
  • Patients are able to self-inject or have a designee or healthcare professional who can inject the study medication at the appropriate intervals.
  • Patient's with long standing (>5Y), as well as recently diagnosed Crohn's disease ,will be eligible if they show radiologic (i.e. CT enterography, MR enterography , small bowel follow through) evidence, as well as laboratory (i.e. CRP, platelets level, fecal calprotectin, ESR ) evidence for an active inflammatory process within a 3 months period prior to the qualifying surgery

Who cannot join

  • evidence of macroscopic inflammatory disease at the surgical margins or else ware, according to the surgeon
  • Patients who discontinued anti TNF-alpha agents due to loss of efficacy or tolerability issues.
  • Patients with temporary ileostomy.
  • Patients with longstanding quiescent CD undergoing surgery for the treatment of a fibrostenotic lesion, without an active inflammatory disease process in the resected segment.
  • Any of the following medications taken within 3 months prior to randomization: cyclosporine, tacrollimus, mycophenolate mofetil, or other investigational anti-inflammatory agents. Medication targeting the reduction of TNF-alpha (infliximab, golimumab, cetrolizumb pegol, etanercept), natalizumab, or other FDA approved biological agents may be administered up until to index surgery.
  • Patient who have an ongoing active infection within the baseline period: intra-abdominal abscess, enteric infection as determined by stool cultures for bacteria, parasites and clostridium difficile toxin, other serious systemic bacterial infection within 3 months before randomization (e.g. Pneumonia; pyelonephritis; meningitis).
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  • Patients with active TB, patients in close contact to individuals with active TB, patients with latent TB whether receiving or not receiving prophylaxis.
  • Patient that have or had an opportunistic infection within the last 6 months
  • Patients seropositive to HIV, HBV, or HCV. Patients will be actively screened for HBV vaccination, and will be required to undergo vaccination according to international guidelines.
  • Patients having current signs/symptoms of severe or progressive systemic disease: any progressive/uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or psychiatric illness.
  • Patients after organ transplantation
  • Any current or known malignancies
  • Use of any investigational drug within 60 days prior to randomization
  • Current/frequent use of NSAIDS (i.e. regular use of NSAIDS for more than 3 times a week for longer than 7 consecutive days during the trial period).
  • Pregnant or lactating women
  • Concomitant substance or alcohol abuse
  • Subjects unable to self-inject or do not have a designee or healthcare professional who can inject the study medication.
  • Subject unable to comply with the planned schedule of study visits and study procedures.
  • Patients with short bowel syndrome
  • Patients with previous small bowel surgeries

Trial locations and contacts

1 site in 1 country.

Erez F Scapa, M.D. contact

972-52-4266345

erezs@tasmc.health.gov.il

Sara Pel, MPH contact

972-3-6973011

sarap@tasmc.health.gov.il

Israel1 site

  • Department of Gastroenterology and Liver Diseases, Tel-Aviv Soursky Medical Center

    Tel Aviv, 64239

    Erez F Scapa, M.D., 972-52-4266345, erezs@tasmc.health.gov.il

    Erez F Scapa, M.D.

Other trials in Israel

About this study

Official title: An Investigator Initiated Prospective, Single Center, Randomized, Open Label Study to Assess the Efficacy of Adalimumab for the Maintenance of Remission in Post-operative CD Patients

This study will be a prospective, open label, randomized, comparative study. Comparing the efficacy of adalimumab with immunomodulator therapy (i.e. 6-mercaptopurine, 6-MP), in maintaining remission of post-operative CD patients, with a high risk of disease recurrence.

Patient assessment for efficacy will be conducted through interval endoscopic surveillance at 24 and 52 weeks.

Read more

Patients in the adalimumab arm, showing endoscopic remission at 52 weeks of therapy, will be re-randomized to either maintain adalimumab therapy for an additional 52 weeks or conclude therapy. A third endoscopic assessment for these patients will be conducted at 104 weeks.

The investigators expect a substantial increase in both endoscopic, as well as clinical remission rate in patients on adalimumab therapy.

Conditions
Crohn Disease
Being tested
Adalimumab, 6 Mercaptopurine
Keywords
Crohn Disease, Colitis Granulomatous, Crohn's Disease, Enteritis Regional, Ileitis Regional, Ileitis Terminal, Ileocolitis
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdalimumabDrug

    Also called Humira

    Subcutaneous adalimumab injections, loading dose of 160 mg and 80 mg on 0 and 2 weeks and maintenance of 40 mg every other week for the duration of the study.

  • 6 MercaptopurineDrug

    Also called Purinethol

    6MP will be administered orally starting at a dose of 6MP of 50mg/day with escalating doses every 1-2 weeks as tolerated, to a target dose of 1-1.5 mg/kg.

    --------------------------------------------------------------------------------

Study groups in NCT01629628
Study groupRoleWhat they receive
AdalimumabExperimentalNot described
Receives: Drug: Adalimumab
6-mercaptopurineActive comparatorNot described
Receives: Drug: 6 Mercaptopurine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of patients with endoscopic recurrence at 12 months, as evaluated by the Rutgeerts endoscopic scoring system.

    Primay outcome measure will assess the efficacy of adalimumab, compared to immunomodulator therapy in maintaining mucosal healing after 52 weeks (1 year).

    Measured: 52 weeks

Secondary outcomes (1)

  1. Proportion of patients in clinical remission at 12 months as assessed by the CDAI score.

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJul 2016 (estimated)
  4. Study completionJul 2016 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01629628
Sponsor's protocol ID
TASMC-10-ES-0446-TLV-CTIL
Acronym
POPART
Status last verified
Jun 2012
First submitted
19 Jun 2012
Last updated
27 Jun 2012
Results posted
No
Data monitoring committee
No

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

  • Hirsch A, Scapa E, Fliss-Isakov N, Tulchinsky H, Itzkowitz E, Kariv Y, Ron Y, Yanai H, White I, Yassin S, Cohen NA, Brazovski E, Dotan I, Maharshak N. Early Initiation of Adalimumab Significantly Diminishes Postoperative Crohn's Disease Endoscopic Recurrence and Is Superior to 6-Mercaptopurine Therapy: An Open-Label, Randomized Controlled Study. J Clin Med. 2023 Dec 10;12(24):7600. doi: 10.3390/jcm12247600.

    PubMed 38137669

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab and 6 Mercaptopurine in people with Crohn Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

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 16 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 27 Jun 2012. 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 Israel. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Erez F Scapa, M.D. (972-52-4266345, erezs@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients with endoscopic recurrence at 12 months, as evaluated by the Rutgeerts endoscopic scoring system. (time frame: 52 weeks). 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 NCT01629628, which also lists 2 linked publications.

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 27 Jun 2012.

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