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 July 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: July 21, 2014
Last verified: July 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: 240
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

  Hide Study Locations
Locations
Austria
Site Reference ID/Investigator# 38142 Withdrawn
Vienna, Austria, 1030
Site Reference ID/Investigator# 38145 Recruiting
Vienna, Austria, 1090
Principal Investigator: Site Reference ID/Investigator# 38145         
Belgium
Site Reference ID/Investigator# 38147 Recruiting
Bonheiden, Belgium, 2820
Principal Investigator: Site Reference ID/Investigator# 38147         
Site Reference ID/Investigator# 38149 Recruiting
Brussels, Belgium, 1200
Principal Investigator: Site Reference ID/Investigator# 38149         
Site Reference ID/Investigator# 43966 Recruiting
Edegem, Belgium, 2650
Principal Investigator: Site Reference ID/Investigator# 43966         
Site Reference ID/Investigator# 38148 Withdrawn
Ghent, Belgium, 9000
Site Reference ID/Investigator# 38151 Recruiting
Leuven, Belgium, 3000
Principal Investigator: Site Reference ID/Investigator# 38151         
Site Reference ID/Investigator# 38150 Recruiting
Liege, Belgium, 4000
Principal Investigator: Site Reference ID/Investigator# 38150         
Site Reference ID/Investigator# 38146 Recruiting
Roeselare, Belgium, 8800
Principal Investigator: Site Reference ID/Investigator# 38146         
Canada
Site Reference ID/Investigator# 38156 Recruiting
Calgary, Canada, T2N 4Z6
Principal Investigator: Site Reference ID/Investigator# 38156         
Site Reference ID/Investigator# 45062 Withdrawn
Hamilton, Canada, L8S 4K1
Site Reference ID/Investigator# 38153 Withdrawn
Montreal, Canada, H3T 1E2
Site Reference ID/Investigator# 44002 Withdrawn
Montreal, Canada, H1T 2M4
Site Reference ID/Investigator# 38157 Withdrawn
Quebec City, Canada, G1S 4L8
Site Reference ID/Investigator# 41942 Withdrawn
Toronto, Canada, M5G 1X5
Site Reference ID/Investigator# 38154 Withdrawn
Vancouver, Canada, V6Z 2K5
Site Reference ID/Investigator# 45502 Recruiting
Vancouver, Canada, V5Z 1M9
Principal Investigator: Site Reference ID/Investigator# 45502         
Site Reference ID/Investigator# 38155 Recruiting
Vaughan, Canada, L4L 4Y7
Principal Investigator: Site Reference ID/Investigator# 38155         
Site Reference ID/Investigator# 38152 Withdrawn
Winnipeg, Canada, R3A 1R9
Czech Republic
Site Reference ID/Investigator# 38159 Recruiting
Hradec Kralove, Czech Republic, 500 12
Principal Investigator: Site Reference ID/Investigator# 38159         
Site Reference ID/Investigator# 38158 Recruiting
Prague 7, Czech Republic, 17004
Principal Investigator: Site Reference ID/Investigator# 38158         
France
Site Reference ID/Investigator# 38164 Recruiting
Amiens, France, 80054
Principal Investigator: Site Reference ID/Investigator# 38164         
Site Reference ID/Investigator# 72513 Recruiting
Clermont-Ferrand Cedex 1, France, 63003
Principal Investigator: Site Reference ID/Investigator# 72513         
Site Reference ID/Investigator# 38163 Recruiting
Lille Cedex, France, 59037
Principal Investigator: Site Reference ID/Investigator# 38163         
Site Reference ID/Investigator# 64742 Recruiting
Marseilles Cedex 20, France, 13015
Principal Investigator: Site Reference ID/Investigator# 64742         
Site Reference ID/Investigator# 42839 Recruiting
Nice, France, 06202
Principal Investigator: Site Reference ID/Investigator# 42839         
Site Reference ID/Investigator# 38165 Withdrawn
Paris Cedex 10, France, 75475
Site Reference ID/Investigator# 42818 Recruiting
Pessac Cedex, France, 33600
Principal Investigator: Site Reference ID/Investigator# 42818         
Site Reference ID/Investigator# 43222 Recruiting
Rouen, France, 76031
Principal Investigator: Site Reference ID/Investigator# 43222         
Site Reference ID/Investigator# 66182 Recruiting
Vandoeuvre les Nancy Cedex, France, 54511
Principal Investigator: Site Reference ID/Investigator# 66182         
Germany
Site Reference ID/Investigator# 38167 Withdrawn
Berlin, Germany, 13353
Site Reference ID/Investigator# 38172 Completed
Dachau, Germany, 85221
Site Reference ID/Investigator# 38169 Completed
Hamburg, Germany, 22559
Site Reference ID/Investigator# 38171 Withdrawn
Hannover, Germany, 30625
Site Reference ID/Investigator# 38170 Completed
Kiel, Germany, 24100
Site Reference ID/Investigator# 44042 Completed
Leipzig, Germany, 04105
Site Reference ID/Investigator# 38168 Completed
Magdeburg, Germany, 39120
Hungary
Site Reference ID/Investigator# 61053 Withdrawn
Budapest, Hungary, 1083
Site Reference ID/Investigator# 64362 Completed
Budapest, Hungary, 1088
Site Reference ID/Investigator# 65277 Not yet recruiting
Budapest, Hungary, 1062
Principal Investigator: Site Reference ID/Investigator# 65277         
Site Reference ID/Investigator# 65276 Withdrawn
Pecs, Hungary, 7624
Israel
Site Reference ID/Investigator# 38174 Recruiting
Haifa, Israel, 31096
Principal Investigator: Site Reference ID/Investigator# 38174         
Site Reference ID/Investigator# 61275 Recruiting
Jerusalem, Israel, 91031
Principal Investigator: Site Reference ID/Investigator# 61275         
Site Reference ID/Investigator# 61276 Recruiting
Jerusalem, Israel, 9112001
Principal Investigator: Site Reference ID/Investigator# 61276         
Site Reference ID/Investigator# 61277 Recruiting
Tel Aviv, Israel, 64239
Principal Investigator: Site Reference ID/Investigator# 61277         
Italy
Site Reference ID/Investigator# 46962 Completed
Florence, Italy, 50134
Site Reference ID/Investigator# 41382 Withdrawn
Milan, Italy, 20157
Site Reference ID/Investigator# 38178 Recruiting
Rome, Italy, 00152
Principal Investigator: Site Reference ID/Investigator# 38178         
Site Reference ID/Investigator# 38176 Recruiting
Rome, Italy, 00168
Principal Investigator: Site Reference ID/Investigator# 38176         
Site Reference ID/Investigator# 38177 Recruiting
Rozzano, Italy, 20089
Principal Investigator: Site Reference ID/Investigator# 38177         
Site Reference ID/Investigator# 40984 Withdrawn
San Donato Milanese - Milan, Italy, 20097
Netherlands
Site Reference ID/Investigator# 38181 Recruiting
Alkmaar, Netherlands, 1815 JD
Principal Investigator: Site Reference ID/Investigator# 38181         
Site Reference ID/Investigator# 38179 Recruiting
Amersfoort, Netherlands, 3813 TZ
Principal Investigator: Site Reference ID/Investigator# 38179         
Site Reference ID/Investigator# 43042 Recruiting
Amsterdam, Netherlands, 1105 AZ
Principal Investigator: Site Reference ID/Investigator# 43042         
Site Reference ID/Investigator# 38180 Recruiting
Leiden, Netherlands, 2333 ZA
Principal Investigator: Site Reference ID/Investigator# 38180         
Site Reference ID/Investigator# 93353 Recruiting
Sittard-Geleen, Netherlands, 6162 BG
Principal Investigator: Site Reference ID/Investigator# 93353         
Poland
Site Reference ID/Investigator# 60903 Recruiting
Warsaw, Poland, 02-507
Principal Investigator: Site Reference ID/Investigator# 60903         
Site Reference ID/Investigator# 63364 Withdrawn
Warsaw, Poland, 02-781
Romania
Site Reference ID/Investigator# 69642 Recruiting
Bucharest, Romania, 022328
Principal Investigator: Site Reference ID/Investigator# 69642         
Site Reference ID/Investigator# 69643 Recruiting
Bucharest, Romania, 022328
Principal Investigator: Site Reference ID/Investigator# 69643         
Site Reference ID/Investigator# 93235 Recruiting
Bucharest, Romania, 020125
Principal Investigator: Site Reference ID/Investigator# 93235         
Site Reference ID/Investigator# 93233 Recruiting
Iasi, Romania, 700506
Principal Investigator: Site Reference ID/Investigator# 93233         
Site Reference ID/Investigator# 93234 Recruiting
Targu Mures, Romania, 540103
Principal Investigator: Site Reference ID/Investigator# 93234         
Site Reference ID/Investigator# 69644 Recruiting
Timisoara, Romania, 300002
Principal Investigator: Site Reference ID/Investigator# 69644         
South Africa
Site Reference ID/Investigator# 110835 Recruiting
Claremont, South Africa, 7708
Principal Investigator: Site Reference ID/Investigator# 110835         
Site Reference ID/Investigator# 109076 Recruiting
Panorama, South Africa, 7500
Principal Investigator: Site Reference ID/Investigator# 109076         
Spain
Site Reference ID/Investigator# 62624 Withdrawn
Barcelona, Spain, 08003
Site Reference ID/Investigator# 38185 Completed
Madrid, Spain, 28006
Site Reference ID/Investigator# 42045 Withdrawn
Madrid, Spain, 28009
Site Reference ID/Investigator# 40462 Withdrawn
Majadahonda (Madrid), Spain, 28222
Site Reference ID/Investigator# 38186 Recruiting
Zaragoza, Spain, 50009
Principal Investigator: Site Reference ID/Investigator# 38186         
Sweden
Site Reference ID/Investigator# 39065 Recruiting
Gothenburg, Sweden, 41345
Principal Investigator: Site Reference ID/Investigator# 39065         
Site Reference ID/Investigator# 39064 Recruiting
Lund, Sweden, 22185
Principal Investigator: Site Reference ID/Investigator# 39064         
Site Reference ID/Investigator# 39066 Recruiting
Orebro, Sweden, 70185
Principal Investigator: Site Reference ID/Investigator# 39066         
Site Reference ID/Investigator# 39062 Recruiting
Stockholm, Sweden, 171 76
Principal Investigator: Site Reference ID/Investigator# 39062         
Site Reference ID/Investigator# 39063 Withdrawn
Stockholm, Sweden, 11883
Site Reference ID/Investigator# 39082 Recruiting
Uppsala, Sweden, 75181
Principal Investigator: Site Reference ID/Investigator# 39082         
Switzerland
Site Reference ID/Investigator# 38189 Withdrawn
Basel, Switzerland, 4031
Site Reference ID/Investigator# 38192 Recruiting
Bern, Switzerland, 3010
Principal Investigator: Site Reference ID/Investigator# 38192         
Site Reference ID/Investigator# 38191 Recruiting
Zurich, Switzerland, 8091
Principal Investigator: Site Reference ID/Investigator# 38191         
Turkey
Site Reference ID/Investigator# 71752 Recruiting
Ankara, Turkey, 06100
Principal Investigator: Site Reference ID/Investigator# 71752         
Site Reference ID/Investigator# 71748 Recruiting
Edirne, Turkey, 22031
Principal Investigator: Site Reference ID/Investigator# 71748         
Site Reference ID/Investigator# 71747 Recruiting
Istanbul, Turkey, 34098
Principal Investigator: Site Reference ID/Investigator# 71747         
Site Reference ID/Investigator# 71750 Recruiting
Istanbul, Turkey, 34093
Principal Investigator: Site Reference ID/Investigator# 71750         
Site Reference ID/Investigator# 73753 Recruiting
Istanbul, Turkey, 34349
Principal Investigator: Site Reference ID/Investigator# 73753         
Site Reference ID/Investigator# 125705 Recruiting
Istanbul, Turkey, 34093
Principal Investigator: Site Reference ID/Investigator# 125705         
Site Reference ID/Investigator# 71749 Recruiting
Izmir, Turkey, 35360
Principal Investigator: Site Reference ID/Investigator# 71749         
Site Reference ID/Investigator# 71751 Recruiting
Izmir, Turkey, 35340
Principal Investigator: Site Reference ID/Investigator# 71751         
Ukraine
Site Reference ID/Investigator# 68925 Recruiting
Donetsk, Ukraine, 83017
Principal Investigator: Site Reference ID/Investigator# 68925         
Site Reference ID/Investigator# 69266 Recruiting
Kharkiv, Ukraine, 61039
Principal Investigator: Site Reference ID/Investigator# 69266         
Site Reference ID/Investigator# 70033 Recruiting
Kharkiv, Ukraine, 61058
Principal Investigator: Site Reference ID/Investigator# 70033         
Site Reference ID/Investigator# 68926 Recruiting
Lviv, Ukraine, 79010
Principal Investigator: Site Reference ID/Investigator# 68926         
Site Reference ID/Investigator# 70034 Recruiting
Odesa, Ukraine, 65025
Principal Investigator: Site Reference ID/Investigator# 70034         
Site Reference ID/Investigator# 68922 Recruiting
Poltava, Ukraine, 36024
Principal Investigator: Site Reference ID/Investigator# 68922         
Site Reference ID/Investigator# 69265 Recruiting
Simferopol, Ukraine, 95017
Principal Investigator: Site Reference ID/Investigator# 69265         
Site Reference ID/Investigator# 68924 Recruiting
Vinnytsya, Ukraine, 21029
Principal Investigator: Site Reference ID/Investigator# 68924         
United Kingdom
Site Reference ID/Investigator# 43987 Recruiting
Liverpool, United Kingdom, L7 8XP
Principal Investigator: Site Reference ID/Investigator# 43987         
Site Reference ID/Investigator# 38194 Withdrawn
Nottingham, United Kingdom, NG7 2UH
Site Reference ID/Investigator# 38196 Recruiting
Oxford, United Kingdom, OX3 9DU
Principal Investigator: Site Reference ID/Investigator# 38196         
Site Reference ID/Investigator# 44162 Withdrawn
Portsmouth, United Kingdom, PO6 3LY
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: July 21, 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'Ordre des Médecins
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
Prednisone
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on August 01, 2014