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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

November 4, 2010
October 8, 2014
February 2011
May 2016   (final data collection date for primary outcome measure)
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.
Rate of mucosal healing as defined by the Crohn's Disease Endoscopic Index of Severity (CDEIS) score at week 56 [ Time Frame: 56 weeks ] [ 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.
Complete list of historical versions of study NCT01235689 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 enzyme-linked immunosorbent assay (ELISA) method. [ Time Frame: 56 weeks ] [ 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 enzyme-linked immunosorbent assay (ELISA) 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 week 56 or 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.
Not Provided
Not Provided
 
Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease
An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects With Moderate to Severe Crohn's Disease

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn's Disease
  • 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: Tight Control
    The Tight Control arm manages disease activity using more stringent criteria than the Clinically Driven arm.
    Interventions:
    • Biological: adalimumab
    • Drug: prednisone
    • Drug: azathioprine
  • Active Comparator: Clinically Driven
    The Clinically Driven arm manages disease activity using less stringent criteria.
    Interventions:
    • Biological: adalimumab
    • Drug: prednisone
    • Drug: azathioprine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
255
May 2016
May 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Paloma Mendez, BS +34913343973 paloma.mendez@abbvie.com
Contact: Bialek Sandra, BS (847) 935-0484 sandra.bialek@abbvie.com
Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Poland,   Romania,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom
 
NCT01235689
M11-271, 2010-020137-10
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Roopal Thakker, MD AbbVie
AbbVie
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP