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

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2010-020137-10-GB
• Date of registration: 19/07/2010
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM)
• Scientific title: An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM
• Date of first enrolment: 20/09/2010
• Target sample size: 240
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020137-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: adalimumab versus combination therapy; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Lithuania, Netherlands, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Clinical Trials Helpdesk
• Affiliation: Abbvie Ltd

• Name: Clinical Trials Helpdesk
• Affiliation: Abbvie Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
• Males and females between ages 18 and 75 years of age at the Baseline visit.
• Diagnosis of ileal, colonic (including rectal) or ileocolonic Crohn's Disease (CD) confirmed using imaging technology or endoscopy not more than 6 years prior to Baseline.
• Moderate to severe Crohn's Disease defined as CDAI score = 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, JAK inhibitor, alpha-integrin inhibitors)
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn's disease
MedDRA version: 17.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Trade Name: Humira 40 mg solution for injection in pre-filled syringe


Product Name: adalimumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten
Product Name: azathioprine
Pharmaceutical Form: Tablet
INN or Proposed INN: Azathioprine
CAS Number: 446-86-6
Other descriptive name: AZATHIOPRINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten
Product Name: azathioprine
Pharmaceutical Form: Tablet
INN or Proposed INN: Azathioprine
CAS Number: 446-86-6
Other descriptive name: AZATHIOPRINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Decortin 5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Decortin 20 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

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 at 48
weeks after randomization.

Secondary Objective: To assess the pharmacokinetics (PK) of adalimumab following subcutaneous administration.

Timepoint(s) of evaluation of this end point: Up to 56 weeks which could include up to an 8 week prednisone run in
and 48 weeks of randomisation.

Main Objective: To demonstrate that tight control of disease activity using stringent
criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing 48 weeks post randomization, as compared to management using less stringent criteria based on CDAI and corticosteroid use.

Secondary Outcome(s)

Secondary end point(s): Proportion of subjects with mucosal healing (CDEIS < 4) and CDEIS < 4 in every segment on ileocolonoscopy at 48 weeks after randomization

Timepoint(s) of evaluation of this end point: Up to 56 weeks which could include up to an 8 week prednison run in and 48 weeks randomisation.

Secondary ID(s)

M11-271

NCT01235689

Source(s) of Monetary Support

Abbvie Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 31/12/2017
• Date Completed: 05/01/2017
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-020137-10/results