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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

• Males and females between ages 18 and 75 years of age at the Baseline visit.
• Diagnosis of colonic or ileocolonic Crohn's Disease (CD) confirmed using imaging technology or endoscopy not more than 4 years prior to Baseline.
• Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450 at the Baseline visit in subjects not receiving prednisone or equivalent at Baseline. CDAI score of >= 200 and <= 450 at the Baseline visit if the subject is receiving prednisone <= 20 mg or equivalent for >= 7 days before Baseline. CDAI score of > 150 and <= 450 at the Baseline visit if the subject is receiving prednisone > 20 mg or equivalent for >= 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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) 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.
• 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 (New York Heart Association 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that tight control of disease activity using stringent<br>criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing at Week 56, as compared to management using less stringent criteria based on CDAI and corticosteroid use. ;Secondary Objective: To assess the pharmacokinetics (PK) of adalimumab following subcutaneous administration.;Primary end point(s): The primary efficacy variable is the proportion of subjects with mucosal healing (CDEIS < 4) and no deep ulcerations on ileocolonoscopy (absence of all deep ulcerations in all segments explored in CDEIS) at Week 56.;Timepoint(s) of evaluation of this end point: 56 Weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Proportion of subjects with mucosal healing (CDEIS < 4) and CDEIS < 4 in every segment on ileocolonoscopy at Week 56.;Timepoint(s) of evaluation of this end point: 56 Weeks

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Updated 5/6/2024