Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01817972
• Date of registration: 19/03/2013
• Prospective Registration: No
• Primary sponsor: Gastroenterology Research of America
• Public title: Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease
• Scientific title: A Phase III, Randomized, Double-blind Trial in the Comparison of Cimzia Versus Cimzia Plus Azathioprine in the Change in Mean SES-CD (Simple Endoscopic Scores-Crohn's Disease) Scores in the Treatment of Active, Moderate to Severe Crohn's Disease
• Date of first enrolment: March 2013
• Target sample size: 65
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01817972
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Carlo M Taboada, MD

• Name: Carlo M Taboada, MD
• Affiliation: Gastroenterology Research of America

• Name: Charles W Randall, MD
• Affiliation: Gastroenterology Research of America

Key inclusion & exclusion criteria

Inclusion Criteria:

1. The patient has signed an Informed Consent Form (ICF).

2. The patient is ambulatory, community-dwelling male or non-pregnant female and is aged
between 18 and 70 years at the Screening Visit. Lactating females must agree not to
breastfeed.

3. Sexually active female patients of childbearing potential must agree to use one of
the following methods of birth control from the date they sign the ICF until the
conclusion of the trial:

a. Hormonal contraception (i.e. oral contraceptive, contraceptive implant, or
injectable hormonal contraceptive) b. Double-barrier birth control (e.g. condom plus
intrauterine device, diaphragm plus spermicide) c. Surgical sterilization (i.e.
bilateral oophorectomy, hysterectomy, or tubal ligation) d. Maintenance if a
monogamous relationship with a male partner who has been surgically sterilized by
vasectomy

4. Females of childbearing potential must have a negative serum pregnancy test at the
Randomization Visit (first study treatment visit) prior to dosing.

5. Patient has no clinically significant findings on a physical examination, 12-lead
electrocardiogram (ECG) and clinical laboratory tests (clinical chemistry panel,
complete blood count [CBC], urinalysis [UA]) after signing the ICF but before
receiving the first dose of study drug. (Note: The Investigator will determine if a
particular finding is clinically significant. In making this determination, the
investigator will consider whether the particular finding could prevent the patient
from performing any of the protocol-specified assessments, could represent a
condition that would exclude the patient from the trial, could represent a safety
concern if the patient participates in the trial, or could confound the
trial-specified assessments of safety or efficacy.)

6. Patient is fluent in English.

7. Are considered eligible according to the following TB screening criteria:

• Have no history of latent or active TB prior to screening. An exception is made for
patients with a history of latent TB and documentation of having completed
appropriate treatment for latent TB within 3 years prior to the first administration
of study agent. Appropriate documentation to verify that there had been treatment
with a antituberculous treatment must be established prior to study participation.

• Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination.

• Have no recent close contact with a person with active TB.

• Subject has a negative purified protein derivative test within 30 days prior to the
first dose. Tuberculin skin tests should be considered positive when they have
greater than or equal to 5 mm of induration at 48 to 72 hours after test is placed.
Subjects with a positive tuberculin skin test (if less than or equal to 14 mm of
induration) are allowed if they have a history of Bacillus Calmette-Guerin
vaccination with a negative Quantiferon test in the past year, no symptoms per
tuberculosis workup, and a negative chest X-ray.

8. Be able to adhere to the required study visit schedule and comply with noted protocol
requirements.

9. Subject has established ileal, ileo-colonic, or colonic Crohn's disease for a minimum
of 3 months.

10. Subject has moderately to severely active Crohn's disease, as defined by a Crohn's
Disease Activity Index (CDAI) score from 225 to 450 at screening and baseline and
must also have an SES score that falls under the auspice of moderate to moderately
severe disease (10-15).

11. Subject has evidence of active inflammation, as demonstrated by any of the following:

- Elevated C reactive protein (CRP) at screening (>2.87 mg/L, or upper limit of
normal (ULN) as set by local laboratory)

- Endoscopic evidence of inflammation during the screening period or within 8
weeks prior to the screening period

12. Subjects are allowed to continue on concurrent treatment with the following agents:

- 5-aminosalicylates, if stable dosage for at least 2 weeks prior to screening
(same dosage to be maintained throughout the trial)

- Probiotics, provided that the dose has been stable for the 2 weeks prior to
enrollment

- Antidiarrheals (eg, loperamide, Imodium) for control of chronic diarrhea; as per
standard CDAI protocols, the use of antidiarrheals will be assessed at each
visit.

Additional eligibility information

SES-CD The subject has a diagnosis of active moderate to severe CD at screening with these
specific findings: the presence of large ulcerations (0.5cm is the minimal diameter in
size to be categorized as large - this also constitutes between 2-3 points on the SES-CD
score), the extent of ulcerated surface (the minimal percentage has got to be at least 10%
- this also constitutes between 2-3 points on the SES-CD score), the extent of the
affected surface (50% is the minimal percentage to fall in the moderate category - would
constitute between 2-3 points on the SES-CD score) and finally the presence and type of
narrowing found (number of strictures found and if the colonoscope can be passed or cannot
be passed - this also constitutes between 2-3 points on the SES-CD score). The minimal
score will be between 10 and 15. The local endoscopist (investigator) will determine
whether subjects meet the entrance criteria from the SES scoring perspective. An appendix
will be attached to define in a table the simple endoscopic scoring for Crohn's Disease
(Appendix 1).

CDAI Crohn's Disease Activity Index scoring: this consists of eight variables including
five subject reported outcomes. Variables 1,2,3,4 and 5 will be obtained from the
patient's diary (see table 2a, subject diary, under Appendix 2, Crohn's Disease Activity
Index Variables) completed by the patient during the 7 days prior to each CDAI evaluation.
The Standard Height and Weight Table (Table 2b) must be used to calculate variable 8. The
score from each variable is weighted by applying the multiplier shown. The total CDAI
score is then determined by calculating the sum of the individual, weighted scores. A
minimum score of 225 points is required and cannot exceed 450. These are the two primary
criteria for entry that have to do with the study outcomes proposed.

Exclusion Criteria:

1. The patient has any condition, including clinically significant abnormalities on
Screening laboratory test and/or medical history found during Screening assessments,
or any acute or chronic condition, that, in the opinion of the investigator,


Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Azathioprine

Biological: Certolizumab pegol

Primary Outcome(s)

Change in mean simple endoscopic scoring achieved by monotherapy versus combination therapy [Time Frame: At the beginning of the study and at week 27 of the study]

Secondary Outcome(s)

Assess differences in response rates and remission rates between the two groups [Time Frame: At week 27 of the study which is their end of treatment study visit]

Assess differences in response rates and remission rates between the two groups [Time Frame: At week 34 end of study]

Secondary ID(s)

CP-GAME01

Randall 2010-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

UCB Pharma