Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01235689
First received: November 4, 2010
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

Efficacy and Safety of two treatment models in subjects with moderate to severe Crohn's Disease.


Condition Intervention Phase
Crohn's Disease
Biological: adalimumab
Drug: prednisone
Drug: azathioprine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects With Moderate to Severe Crohn's Disease

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Rate of mucosal healing as defined by the Crohn's Disease Endoscopic Index of Severity (CDEIS) score at 48 weeks after Randomization [ Time Frame: 48 weeks after Randomization ] [ Designated as safety issue: No ]
    The CDEIS score is a clinical measure of mucosal healing in Crohn's Disease. The CDEIS is based upon presence of ulcers and/or stenosis in the 5 segments of the colon. Also included in the CDEIS; the percentage of ulcerated surface and the percentage of surface affected by the disease.


Secondary Outcome Measures:
  • Assess Pharmacokinetics (PK) of adalimumab following subcutaneous injection; a PK blood draw at protocol defined time points. Serum concentrations of adalimumab will be determined using a validated Ligand binding assay (LBA) method. [ Time Frame: 48 weeks after Randomization ] [ Designated as safety issue: No ]
    Subjects will have a PK blood draw at protocol defined time points. Serum concentrations of adalimumab will be determined using a validated Ligand binding assay (LBA) method.

  • Safety will be assessed through clinical laboratory tests, vital signs, physical exams and adverse event assessments. [ Time Frame: Starting the day Informed Consent is signed through the study to Final/Early Termination. In addition, 70 days after the last visit, the site will contact the subject to collect any safety data. ] [ Designated as safety issue: Yes ]
    Safety will be assessed through clinical laboratory tests, vital signs, physical exams and adverse event assessments.


Estimated Enrollment: 255
Study Start Date: February 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tight Control
The Tight Control arm manages disease activity using more stringent criteria than the Clinically Driven arm.
Biological: adalimumab
Subject will be assigned to this intervention during the study upon Success Criteria evaluations.
Other Name: ABT-D2E7 Humira
Drug: prednisone
All subjects will start this intervention upon enrollment into the study except those that Early Randomize and meet protocol specific criteria. Depending on the evaluation criteria subjects may continue this therapy or stop it during the study.
Drug: azathioprine
Subjects will start this therapy after moving through all other therapeutic options. This will be used in conjunction with adalimumab and once assigned to this intervention, the subject will continue taking it until they complete the study or discontinue.
Active Comparator: Clinically Driven
The Clinically Driven arm manages disease activity using less stringent criteria.
Biological: adalimumab
Subject will be assigned to this intervention during the study upon Success Criteria evaluations.
Other Name: ABT-D2E7 Humira
Drug: prednisone
All subjects will start this intervention upon enrollment into the study except those that Early Randomize and meet protocol specific criteria. Depending on the evaluation criteria subjects may continue this therapy or stop it during the study.
Drug: azathioprine
Subjects will start this therapy after moving through all other therapeutic options. This will be used in conjunction with adalimumab and once assigned to this intervention, the subject will continue taking it until they complete the study or discontinue.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ileal, colonic (including rectal), or ileocolonic CD confirmed using imaging technology or endoscopy not more than 6 years prior to Baseline.
  • CDAI score of greater than or equal to 220 and less than or equal to 450 at the Baseline visit in subjects not receiving prednisone or equivalent at Baseline. CDAI score of greater than or equal to 200 and less than or equal to 450 at the Baseline visit if the subject is receiving prednisone less than or equal to 20 mg or equivalent for greater than or equal to 7 days before Baseline. CDAI score of greater than 150 and less than or equal to 450 at the Baseline visit if the subject is receiving prednisone greater than 20 mg or equivalent for greater than or equal to 7 days before Baseline
  • Subjects or his/her legal representative have voluntarily signed and dated an informed consent approved by and compliant with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
  • Adequate cardiac, renal and hepatic function as determined by the Principal Investigator and demonstrated by Screening laboratory evaluations, questionnaires and physical examination results that do not indicate an abnormal clinical condition which would place the subject at undue risk and thus preclude subject participation in the study.
  • Subjects must be able to self-inject and orally administer study medication or have a designee or Healthcare Professional who can assist

Exclusion Criteria:

  • Previous or current biologic use for Crohn's disease or participation in a biologic study
  • Previous or current use of immunomodulators (e.g., methotrexate, azathioprine, 6-mercaptopurine, JAK inhibitor, alpha-integrin) for Crohn's disease or participation in a Crohn's disease study with immunomodulator(s). Current use of immunomodulators for non-Crohn's disease at Baseline.
  • Exclusion Criterion deleted in Amendment 3-"Receiving systemic corticosteroid for Crohn's disease at a dose of prednisone equivalent greater than to 20 mg per day or budesonide greater than 6 mg per day at Screening."
  • Subjects with a poorly controlled medical condition such as: uncontrolled diabetes with documented history of recurrent infections, unstable ischemic heart disease, moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the Investigator or the sponsor, would put the subject at risk by participation in the protocol
  • Subjects with positive C. difficile stool assay at Screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235689

Contacts
Contact: Paloma Mendez, BS +34913343973 paloma.mendez@abbvie.com
Contact: Bialek Sandra, BS (847) 935-0484 sandra.bialek@abbvie.com

  Show 101 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Roopal Thakker, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01235689     History of Changes
Other Study ID Numbers: M11-271, 2010-020137-10
Study First Received: November 4, 2010
Last Updated: October 8, 2014
Health Authority: Canada: Health Canada
France: French Data Protection Authority
France: Institutional Ethical Committee
Sweden: Medical Products Agency
Austria: Federal Office for Safety in Health Care
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Spanish Agency of Medicines
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)
Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Ethics Commission
Germany: Paul-Ehrlich-Institut
Italy: Ethics Committee
Switzerland: Swissmedic
Switzerland: Ethikkommission
European Union: European Medicines Agency
France: Conseil National de l
Sweden: Regional Ethical Review Board
Sweden: Swedish Data Inspection Board
Israel: Ministry of Health
Hungary: Institutional Ethics Committee
Hungary: National Institute of Pharmacy
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
Ukraine: Ethics Committee
Ukraine: State Pharmacological Center - Ministry of Health
Turkey: Ethics Committee
Turkey: Ministry of Health
Romania: Ethics Committee
Romania: National Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
South Africa: National Health Research Ethics Council
South Africa: Medicines Control Council
South Africa: Human Research Ethics Committee

Keywords provided by AbbVie:
Efficacy and Safety of two treatment algorithms in Subjects with Moderate to Severe Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Azathioprine
Adalimumab
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on October 19, 2014