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

NCT01817972 | Unknown Phase 3

• 2 other identifiers: CP-GAME01Randall 2010-02
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double blind trial of combination therapy (Cimzia plus Azathioprine) versus mono therapy (Cimzia alone) and the improvement in mean SES-CD (Simple Endoscopic Scoring in Crohn's Disease) score. It is a trial where the investigators are administering biological therapy by itself and biological therapy plus an immunosuppressive medicine in combination to see which form of therapy has a better effect on healing ulcerations in the small intestine and colon that are due to a flare up of Crohn's disease.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Crohn's colitis; Crohn's ileocolitis

Outcome Measures

Primary Outcomes (1)

• Change in mean simple endoscopic scoring achieved by monotherapy versus combination therapy

  The primary objective is to compare the change in mean SES-CD score achieved by combination therapy (Cimzia plus AZP) versus mono therapy (Cimzia alone). A colonoscopy will be performed at the beginning of the trial and at the conclusion of the treatment period to see if there were any changes between the two treatment groups.

  At the beginning of the study and at week 27 of the study

Secondary Outcomes (2)

• Assess differences in response rates and remission rates between the two groups

  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

  At week 34 end of study

Study Arms (2)

Certolizumab pegol-Placebo Azathioprine

PLACEBO COMPARATOR

Certolizumab pegol (Cimzia) 400mg Subcutaneous injection (per standard induction protocol) - which is at week 0, week 2, week4, week 6, then every 4 weeks until week 26. You will also be receiving Azathioprine placebo tablets at a dosage of 1.5mg per kilogram of body weight once a day for 26 weeks. They will be 50mg tablets. This is not active Azathioprine.

Biological: Certolizumab pegol

Certolizumab pegol plus Azathioprine

ACTIVE COMPARATOR

Certolizumab pegol (Cimzia) 400mg Subcutaneous injection (per standard induction protocol) - which is at week 0, week 2, week4, week 6, then every 4 weeks until week 26. You will also be receiving Azathioprine tablets at a dosage of 1.5mg per kilogram of body weight once a day for 26 weeks. They will be 50mg tablets.

Biological: Certolizumab pegol; Drug: Azathioprine

Interventions

Certolizumab pegol BIOLOGICAL

Subcutaneous injection

Also known as: Cimzia

Certolizumab pegol plus Azathioprine; Certolizumab pegol-Placebo Azathioprine

Azathioprine DRUG

50mg tablets

Also known as: Imuran, Azasan, generic Azathioprine

Certolizumab pegol plus Azathioprine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has signed an Informed Consent Form (ICF).
• 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.
• 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
• Females of childbearing potential must have a negative serum pregnancy test at the Randomization Visit (first study treatment visit) prior to dosing.
• 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.)
• Patient is fluent in English.
• 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.
• Be able to adhere to the required study visit schedule and comply with noted protocol requirements.
• Subject has established ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 3 months.
• 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).

You may not qualify if:

• 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, constitutes a risk for the patient or a contraindication for participation in and completion of the study, or could interfere with study objectives, conduct, or evaluations (such as unstable diabetes mellitus, thyroid disease, vascular disease, end-stage coronary disease, pulmonary disease, liver disease, renal disease and any metabolic disorders that are also uncontrolled).
• The patient has major surgery scheduled during the study period.
• The patient has a history of cancer, except for adequately treated basal cell carcinoma of the skin, cervical dysplasia, or carcinoma in situ of the skin or the cervix.
• Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or for a 6-month period thereafter.
• Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product (plasma-derived or recombinant, e.g. monoclonal antibody).
• Have received within 3 months prior to screening or are expected to receive any live viral (e.g. small-pox) or live bacterial vaccinations during the trial or up to 3 months after the last administration of study agent.
• Have evidence of an active infection at the time of randomization or have had a serious infection not related to CD (e.g., hepatitis, pneumonia, or pyelonephritis), within 6 months prior to screening.
• Have or have had an opportunistic infection (e.g., herpes zoster \[shingles\], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening. Have current active hepatitis B (including chronic active hepatitis B or asymptomatic carrier state \[hepatitis B surface antigen positive; HBsAg-positive\]) or a history of hepatitis C infection.
• Chronic pancreatitis.
• Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
• Have multiple sclerosis or other central demyelinating disorder.
• Have a history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, intraclavicular, epitrochlear, or periaortic areas), or splenomegaly.
• Have a transplanted organ (with the exception of a corneal transplant performed \> 3 months prior to screening).
• Have documented or suspected human immunodeficiency virus (HIV) infection.
• Evidence of abdominal abscess at the initial screening visit

Sponsors & Collaborators

• Gastroenterology Research of America: lead
• UCB Pharma: collaborator

Study Sites (1)

Gastroenterology Research of America

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Certolizumab Pegol; Azathioprine; Adenosine Triphosphate

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Adenine Nucleotides; Purine Nucleotides; Nucleotides; Ribonucleotides

Study Officials

• Charles W Randall, MD

  Gastroenterology Research of America

  PRINCIPAL INVESTIGATOR

• Carlo M Taboada, MD

  Gastroenterology Research of America

  STUDY DIRECTOR

Central Study Contacts

Carlo M Taboada, MD

CONTACT

2109490083; drcmtaboada@gmail.com

Lauren K Reeves, BS

CONTACT

2106153848; laurenk.reeves@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 26, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 26, 2013

Record last verified: 2013-03

Locations

US (1)