Crohn's DiseasePhase 4NCT01024647
Optimizing Cimzia in Crohn's Patients
A Phase 4 study testing certolizumab pegol in people with Crohn's Disease, run by Atlanta Gastroenterology Associates at 1 site in United States.
Trial summary
The purpose of this study is to determine if increasing the dose and/or dosing frequency of certolizumab pegol (Cimzia) is effective in regaining and optimizing response in patients with moderate to severe Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- certolizumab pegol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to May 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ileal and/or colonic Crohn's disease
- moderate to severe Crohn's disease
Who cannot join
- short bowel syndrome
- ostomy
- anti-TNF therapy within 4 weeks
- prior certolizumab therapy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Lamia S Mereby, BSN, 404-257-9000 ext. 2142, lamia.mereby@atlantagastro.com
About this study
Official title: Optimizing Response in Crohn's Disease Patients Who Have Insufficient Initial Response or Who Have Loss of Successful Response to Certolizumab Pegol (Cimzia) Induction Therapy
The purpose of this study is to determine if increasing the dose and/or dosing frequency of certolizumab pegol (Cimzia) is effective in regaining and optimizing response in patients with moderate to severe Crohn's disease.
Read the detailed description
This open label study for patients with moderate to severe Crohn's disease will evaluate treatment options to improve capture of initial response and to regain loss of response to certolizumab pegol (Cimzia). It is a 26 week open label clinical trial that may be extended to 52 weeks in patients who respond to treatment during the initial 26 week study. The following dosing options will be tested: 1) Re-induction (one supplemental dose of 400mg) 2) Dose splitting (200mgQ2W) and 3) Dose Escalation (400mg Q2W. The highest dose in the study, 400mg Q2W, has been used in a large phase III trial (WELCOME) without any new safety signals. Efficacy and safety measures will be monitored.
- Conditions
- Crohn's Disease
- Being tested
- certolizumab pegol
- 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
certolizumab pegol 200 mg every 2 weeks
certolizumab pegolBiological
Also called Cimzia
certolizumab pegol 400 mg every 2 weeks
certolizumab pegolBiological
Also called Cimzia
certolizumab pegol 400 mg every 4 weeks
certolizumab pegolBiological
Also called Cimzia
certolizumab pegol 400 mg every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Loss of Reponse Reinduction Responders | Active comparator | Loss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks Receives: Biological: certolizumab pegol |
| Response loss Reinduction Non-Responders | Active comparator | Response Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks Receives: Biological: certolizumab pegol |
| Responders | Active comparator | Responders: certolizumab pegol(Cimzia) 400 mg every 4 weeks Receives: Biological: certolizumab pegol |
| Non-Responders | Active comparator | Non-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks Receives: Biological: certolizumab pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohn's Disease Activity Index
≥ 100 point decrease in CDAI represents response
Measured: 26 Weeks, if responder up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlanta Gastroenterology Associates
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Principal investigator, Douglas C. Wolf, MD, Atlanta Gastroenterology Associates
- Investigators
- Douglas C Wolf, MD, Principal investigator, Atlanta Gastroenterology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024647
- Sponsor's protocol ID
- CMZ-2010
- Status last verified
- Nov 2012
- First submitted
- 2 Dec 2009
- Last updated
- 5 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Response in Crohn's Disease Patients Who Have Insufficient Initial Response or Who Have Loss of Successful Response to Certolizumab Pegol (Cimzia) Induction Therapy
- ClinicalTrials.gov ID
- NCT01024647
- Acronym / sponsor ID
- CMZ-2010
- Conditions
- Crohn's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Atlanta Gastroenterology AssociatesUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Dec 2009
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 3 Dec 2009 (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.
The purpose of this study is to determine if increasing the dose and/or dosing frequency of certolizumab pegol (Cimzia) is effective in regaining and optimizing response in patients with moderate to severe Crohn's disease.
Detailed description
This open label study for patients with moderate to severe Crohn's disease will evaluate treatment options to improve capture of initial response and to regain loss of response to certolizumab pegol (Cimzia). It is a 26 week open label clinical trial that may be extended to 52 weeks in patients who respond to treatment during the initial 26 week study. The following dosing options will be tested: 1) Re-induction (one supplemental dose of 400mg) 2) Dose splitting (200mgQ2W) and 3) Dose Escalation (400mg Q2W. The highest dose in the study, 400mg Q2W, has been used in a large phase III trial (WELCOME) without any new safety signals. Efficacy and safety measures will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Loss of Reponse Reinduction Responders | Active comparator | Biological: certolizumab pegolLoss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks |
| Response loss Reinduction Non-Responders | Active comparator | Biological: certolizumab pegolResponse Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks |
| Responders | Active comparator | Biological: certolizumab pegolResponders: certolizumab pegol(Cimzia) 400 mg every 4 weeks |
| Non-Responders | Active comparator | Biological: certolizumab pegolNon-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ileal and/or colonic Crohn's disease
- moderate to severe Crohn's disease
Key exclusion criteria (4 listed)
- short bowel syndrome
- ostomy
- anti-TNF therapy within 4 weeks
- prior certolizumab therapy
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: Cimziacertolizumab pegol 200 mg every 2 weeks | Biological | Loss of Reponse Reinduction Responders |
| certolizumab pegolAlso: Cimziacertolizumab pegol 400 mg every 2 weeks | Biological | Response loss Reinduction Non-Responders |
| certolizumab pegolAlso: Cimziacertolizumab pegol 400 mg every 4 weeks | Biological | Responders |
| certolizumab pegolAlso: Cimziacertolizumab pegol 400 mg every 2 weeks | Biological | Non-Responders |
Primary outcome
Crohn's Disease Activity Index
Time frame: 26 Weeks, if responder up to 52 weeks
≥ 100 point decrease in CDAI represents response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2012.
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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.
Douglas C Wolf, MD principal investigator
Atlanta Gastroenterology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing certolizumab pegol in people with Crohn's Disease, run by Atlanta Gastroenterology Associates 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 2 inclusion and 4 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 5 Nov 2012. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Lamia S Mereby, BSN (404-257-9000 ext. 2142, lamia.mereby@atlantagastro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crohn's Disease Activity Index (time frame: 26 Weeks, if responder up to 52 weeks). 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 5 Nov 2012.