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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235689
First Posted: November 5, 2010
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  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
Intervention Model: Parallel Assignment
Masking: None (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 ( AbbVie (prior sponsor, Abbott) ):

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 ]
    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 ]
    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. ]
    Safety will be assessed through clinical laboratory tests, vital signs, physical exams and adverse event assessments.


Enrollment: 255
Study Start Date: February 2011
Study Completion Date: November 2016
Primary Completion Date: November 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 Names:
  • 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 Names:
  • 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  • Greater than two previous courses of corticosteroid (systemic corticosteroid) or budesonide) for Crohn's Disease. A course is defined as 1) total duration for burst and taper ≥ 4 weeks and 2) prednisone or equivalent ≥ 40 mg (or budesonide ≥ 9 mg) for at least 2 weeks.
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235689


  Show 74 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Anne Robinson, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01235689     History of Changes
Other Study ID Numbers: M11-271
2010-020137-10 ( EudraCT Number )
First Submitted: November 4, 2010
First Posted: November 5, 2010
Last Update Posted: October 31, 2017
Last Verified: November 2016

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
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
Prednisone
Adalimumab
Azathioprine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antirheumatic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors