Crohn's DiseasePhase 3NCT01817972
Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease
A Phase 3 study testing Certolizumab pegol and Azathioprine in people with Crohn's Disease, run by Gastroenterology Research of America at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Certolizumab pegol and Azathioprine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Nov 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.)
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- 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).
- 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
- 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.
Who cannot join
- 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.
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- 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
- Extensive colonic resection, subtotal or total colectomy
- History of >3 small bowel resections or diagnosis of short bowel syndrome
- Have received tube feeding, defined formula diets, or parenteral alimentation within 21 days prior to the administration of the first dose of study drug
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- Within 30 days prior to enrollment, have received any of the following for the treatment of underlying disease:
- Non-biologic therapies (e.g., cyclosporine, thalidomide)
- A non-biologic investigational therapy
- An approved non-biologic therapy in an investigational protocol
- 20. Within 60 days prior to enrollment, have received any of the following:
- Infliximab
- Certolizumab pegol
- Adalimumab
- Any other investigational or approved biological agent, other than local injections for non inflammatory bowel disease (IBD) conditions (e.g. intraocular-injections for the treatment of wet macular degeneration) 21. Any prior exposure to natalizumab, efalizumab, or rituximab 22. Evidence of or treatment for C. difficile infection or other intestinal pathogen within 28 days prior to enrollment 23. Have a history of substance abuse (drug or alcohol) within the previous 3 years, history of noncompliance to medical regimens, or other condition/circumstance that could interfere with the patient's adherence to protocol requirements (e.g., psychiatric disease, lack of motivation, travel, etc).
- 24. Have Ulcerative Colitis as their diagnosis 25. Are employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gastroenterology Research of America
San Antonio, Texas, 78229
Charles W Randall, MD
Russell D Havranek, MD
About this study
Official 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
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
- Being tested
- Certolizumab pegol, Azathioprine
- Keywords
- Crohn's Disease, Crohn's colitis, Crohn's ileocolitis
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab pegolBiological
Also called Cimzia
Subcutaneous injection
AzathioprineDrug
Also called Imuran, Azasan, generic Azathioprine
50mg tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Certolizumab pegol; Drug: Azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The secondary efficacy objective is to assess differences in response rates (which we will define for this trial as a drop to ≤10 on SES scoring)between the two groups.
Measured: 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
The secondary efficacy objective is to assess differences in remission rates (no mucosal ulcerations at study end) between the two groups.
Measured: At week 34 end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gastroenterology Research of America
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
- Investigators
- Charles W Randall, MD, Principal investigator, Gastroenterology Research of AmericaCarlo M Taboada, MD, Study director, Gastroenterology Research of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817972
- Sponsor's protocol ID
- CP-GAME01
- Other IDs
- Randall 2010-02
- Status last verified
- Mar 2013
- First submitted
- 19 Mar 2013
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01817972
- Acronym / sponsor ID
- CP-GAME01
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Crohn's colitis, Crohn's ileocolitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Gastroenterology Research of AmericaUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Certolizumab pegol-Placebo Azathioprine | Placebo comparator | Biological: Certolizumab pegolCertolizumab 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. |
| Certolizumab pegol plus Azathioprine | Active comparator | Biological: Certolizumab pegol, Drug: AzathioprineCertolizumab 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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:
- 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.)
Key exclusion criteria (29 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certolizumab pegolAlso: CimziaSubcutaneous injection | Biological | Certolizumab pegol plus Azathioprine, Certolizumab pegol-Placebo Azathioprine |
| AzathioprineAlso: Imuran, Azasan, generic Azathioprine50mg tablets | Drug | Certolizumab pegol plus Azathioprine |
Primary outcome
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
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.
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles W Randall, MD principal investigator
Gastroenterology Research of America
Carlo M Taboada, MD study director
Gastroenterology Research of America
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Certolizumab pegol and Azathioprine in people with Crohn's Disease, run by Gastroenterology Research of America at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo M Taboada, MD (2109490083, drcmtaboada@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2013.