Trial document




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  DRKS00009799

Trial Description

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Title

Ibd CAncer and seRious infections in Europe

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Trial Acronym

I-CARE

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URL of the Trial

http:///

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Brief Summary in Lay Language

Inflammatory bowel diseases (IBD) includes Crohn’s Disease and ulcerative Colitis. It is a chronic, disabling, incurable condition that affects 3 million Europeans. Current therapeutic options are limited and comprise 5ASA, immunosuppressive, anti-TNF and Vedolizumab. New treatment strategies, which are specified in European and national guidelines, aimed at an earlier use of TNF antibody in the treatment of IBD.
It is planned a multicenter inclusion of 1.000 patients in Germany and a total of 17.600 patients in Europe. Planned observation periode- 3 years.

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Brief Summary in Scientific Language

I-CARE is the first observational European prospective study that will provide unique information (safety, efficacy/potential for disease modification, risk-benefit ratio, and healthcare costs) on the long-term use of anti-TNF therapy in IBD, using a predefined standardized follow-up. These real world data will be used to guide clinicians as well as Healthcare authorities to provide the best care for IBD patients by optimizing available therapies. These findings may assist in maximizing benefits and minimizing risks among IBD patients who are candidates for anti-TNF therapy.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00009799
  •   2016/02/12
  •   2015/02/26
  •   yes
  •   Approved
  •   A 115/15, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  •   U1111-1177-6483 
  •   NCT02377258  (Clinicaltrial.gov website)
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Health Condition or Problem studied

  •   K50.0 -  Crohn disease of small intestine
  •   K50.1 -  Crohn disease of large intestine
  •   K51 -  Ulcerative colitis
  •   K52.3 -  Indeterminate colitis
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Interventions/Observational Groups

  •   Group 1:IBD-patients with a diagnosis at least made 3 month earlier, based on usual radiological, endoscopic or histological criteria, and who have never received biological agents or immunosuppressant before. All 5-ASA and steroids formulations are permitted.
    During the period of follow-up of 3 years following parameters are evaluated: Demographic, Disease characteristics, family history, personal history, vaccination and infection history, previous & current medication, biological data
  •   Group 2: IBD-patients with a diagnosis at least made 3 month earlier, based on usual radiological, endoscopic or histological criteria, and receiving thiopurines alone.
    During the period of follow-up of 3 years following parameters are evaluated: Demographic, Disease characteristics, family history, personal history, vaccination and infection history, previous & current medication, biological data
  •   Group 3: IBD-patients with a diagnosis at least made 3 month earlier, based on usual radiological, endoscopic or histological criteria, and treated with anti-TNF therapy alone without any concomitant immunosuppressant.
    During the period of follow-up of 3 years following parameters are evaluated: Demographic, Disease characteristics, family history, personal history, vaccination and infection history, previous & current medication, biological data
  •   Group 4: IBD-patients with a diagnosis at least made 3 month earlier, based on usual radiological, endoscopic or histological criteria, and treated with anti-TNF therapy in combination with thiopurines or methotrexate.
    During the period of follow-up of 3 years following parameters are evaluated: Demographic, Disease characteristics, family history, personal history, vaccination and infection history, previous & current medication, biological data
  •   Group 5: IBD-patients treated with vedolizumab alone and IBD-patients treated with vedolizumab in combination with thiopurines or methotrexate.
    During the period of follow-up of 3 years following parameters are evaluated: Demographic, Disease characteristics, family history, personal history, vaccination and infection history, previous & current medication, biological data
  •   Group 6 (optional): IBD-patients, treated with Ustekinumab with or without concurrent medication. (Only investigators who treat CD-patients with Ustekinumab). During the period of follow up of 3 years following parameters are evaluated: Demographic, Disease characteristics, family history, personal history, vaccination and infection history, previous & current medication, biological data
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary objective of I-CARE study is to assess prospectively the presence and the extent of safety concerns (cancers (especially lymphoma) and serious infections risks) for anti-TNF or other biologicals alone or in combination with thiopurines among IBD patients. Safety profile of all steroids formulation will also be analysed. We will stratify the risk of cancers and seroius infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).
Study duraction 4 years: 1 year inclusion period and 3 years follow-up period

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Secondary Outcome

To investigate prospectively the impact of anti-TNF based strategies or other biologicals on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as muscosal healing and disease complications such as bowel damage, surgeries and hospitalizations.

To assess the evolation of patient-reported outcomes (PROs) on a yearly basis and the impact of anti-TNF agents or other biologicals on PROs in IBD.
1 year inclusion period and 3 years follow-up period.

To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF or other biologicals therapy for IBD.

To assess the healthcare costs and cost-efficacy of current therapeutic straegies in IBD.

Study duraction 4 years: 1 year inclusion period and 3 years follow-up period

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Countries of Recruitment

  •   Germany
  •   Belgium
  •   Denmark
  •   France
  •   United Kingdom
  •   Ireland
  •   Israel
  •   Italy
  •   Netherlands
  •   Poland
  •   Russian Federation
  •   Sweden
  •   Switzerland
  •   Hungary
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • other 
  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
  • other 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • University Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • Medical Center 
  • other 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2016/04/01
  •   17600
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patient with an established diagnosis of Crohn´s disease, ulcerative colits or IBD, unclassified made at least 3 months earlier based on usal radiological, endoscopic or histological criteria.

Patient 18 an older accepting to sign the informed participating consent form, stating that he accepts to provide personal details to complete the electronic studydocumentation as required and to be contacted by a Study Coordinator and his gastroenterologist for the purpose of the study during the entire study period if required.

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Exclusion Criteria

Patient unable to sign the informed consent form.
Patient with no regular access to internet.
Patient refusion to sign informed consent form.
Treatment at entry in the study with an immunomodulator different from thiopurines and methotrexate.
Patient previously enrolled in a randomized clinical trial.

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Addresses

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    • Hoptial Lariboisière- Service de Gastroenterologie
    • Mr.  Prof  Laurent  Peyrin-Biroulet 
    • 2 rue Ambroise Paré
    • 75010  Paris
    • France
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    • Kompetenznetz Darmerkrankungen
    • Hopfenstr. 60
    • 24103  Kiel
    • Germany
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    • Gemeinschaftspraxis
    • Mr.  PD Dr. med.  Ulf  Helwig 
    • Neue Donnerschweer Str. 30
    • 26123  Oldenburg
    • Germany
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    • CED Service GmbH / Kompetenznetz Darmerkrankungen
    • Ms.  Jessica   Höchstödter 
    • Hopfenstr. 60
    • 24103  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • GETAID Hôpital Saint-Louis
    • 1 Avenue Claude Vellefaux
    • 75010  Paris
    • France
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.