Crohn's DiseasePhase 3Welcome2NCT00333788
Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease
A Phase 3 study testing Certolizumab pegol (CDP870) in people with Crohn's Disease, run by UCB Pharma at 65 sites in 12 countries.
Trial summary
The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 [NCT00308581]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters. 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 (CDP870)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 65 sitesin 12 countries
- Study dates
- Oct 2006to Apr 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients having completed study C87042 [NCT00308581] (previously treated with infliximab)
Who cannot join
- Subject withdraw from C87042 [NCT00308581] study
- Subject who received treatment other than certolizumab pegol and other than medications permitted in C87042 [NCT00308581] study
- Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment
- Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration
Trial locations and contacts
65 sites in 12 countries.
65 sites in 12 countries
United States19 sites
Study site
Atlanta, Georgia
Study site
Baton Rouge, Louisiana
Study site
Chapel Hill, North Carolina
Study site
Charleston, North Carolina
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Gainesville, Florida
Study site
Germantown, Tennessee
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Lincoln, Nebraska
Study site
Louisville, Kentucky
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Oklahoma City, Oklahoma
Study site
Portland, Oregon
Study site
Seattle, Washington
Germany8 sites
Study site
Berlin
Study site
Hamburg
Study site
Herne
Study site
Kiel
Study site
Leipzig
Study site
Minden
Study site
München
Study site
Munich
Belgium7 sites
Study site
Bonheiden
Study site
Brussels
Study site
Genk
Study site
Ghent
Study site
Leuven
Study site
Liège
Study site
Roeselare
Italy6 sites
Study site
Bologna
Study site
Milan
Study site
Padova
Study site
Palermo
Study site
Roma
Study site
Torino
Canada5 sites
Study site
Calgary
Study site
Edmonton, Alberta
Study site
London, Ontario
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
France5 sites
Study site
Clichy
Study site
Lille
Study site
Nice
Study site
Paris
Study site
Pessac
Spain5 sites
Study site
Barcelona
Study site
Madrid
Study site
Santiago de Compostela
Study site
Seville
Study site
Valencia
United Kingdom3 sites
Study site
Bristol
Study site
London
Study site
Oxford
About this study
Official title: Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.
The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 [NCT00308581]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.
- Conditions
- Crohn's Disease
- Being tested
- Certolizumab pegol (CDP870)
- Keywords
- Crohn's Disease, Certolizumab pegol, CDP870, Cimzia
- 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 pegol (CDP870)Biological
Also called CDP870, Cimzia
400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks
| Study group | Role | What they receive |
|---|---|---|
| Certolizumab pegol 400 mg | Experimental | 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks Receives: Biological: Certolizumab pegol (CDP870) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection.
Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.
Measured: Maximum 164 weeks
Secondary outcomes (23)
Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).
Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI).
Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response [CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)] at 2 consecutive visits.
A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Results are presented as the percentage of subjects maintaining response at Last visit.
Measured: Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI).
CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Results are presented as the percentage of subjects achieving clinical response at Last visit.
Measured: Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points
CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Results are presented as the percentage of subjects in remission at Last visit.
Measured: Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Measured: Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study
Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI)
Loss of response = both a CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed).
Measured: Maximum 154 weeks
Occurrence of at Least 1 Hospital Stay During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period.
Measured: Maximum 152 weeks
Occurrence of at Least 1 Hospital Stay During the Follow-Up Period
Follow-up period starts the day after the last injection up to 84 days after last injection.
Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period.
Measured: Maximum 12 weeks
Occurrence of at Least 1 Hospital Stay During the During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046.
Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period.
Measured: Maximum 164 weeks
Length of Hospital Stays During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Measured: Maximum 152 weeks
Length of Hospital Stays During the Follow-Up Period
Follow-up period starts the day after the last injection up to 84 days after last injection.
Measured: Maximum 12 weeks
Length of Hospital Stays During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046.
Measured: Maximum 164 weeks
Occurrence of at Least 1 Emergency Room Visit During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period.
Measured: Maximum 152 weeks
Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period
Follow-up period starts the day after the last injection up to 84 days after last injection.
Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period.
Measured: Maximum 12 weeks
Occurrence of at Least 1 Emergency Room Visit During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046.
Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period.
Measured: Maximum 164 weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.
Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period.
Measured: Maximum 152 weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period
Follow-up period start the day after the last injection up to 84 days after last injection.
Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.
Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period.
Measured: Maximum 12 weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046.
Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.
Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period.
Measured: Maximum 164 weeks
Occurrence of at Least 1 General Concomitant Medication During the Treatment Period
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period.
Measured: Maximum 152 weeks
Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period
Follow-up period start the day after the last injection up to 84 days after last injection.
Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period.
Measured: Maximum 12 weeks
Occurrence of at Least 1 General Concomitant Medication During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046.
Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period.
Measured: Maximum 164 weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.
The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.
Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period.
Measured: Maximum 152 weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period
Follow-up period start the day after the last injection up to 84 days after last injection.
Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period.
Measured: Maximum 12 weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period
Overall period corresponds to both treatment and follow-up periods in C87046.
Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period.
Measured: Maximum 164 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startOct 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333788
- Sponsor's protocol ID
- C87046
- Other IDs
- 2006-001729-24
- Acronym
- Welcome2
- Status last verified
- Aug 2011
- First submitted
- 2 Jun 2006
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.
- ClinicalTrials.gov ID
- NCT00333788
- Acronym / sponsor ID
- Welcome2 / C87046
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Certolizumab pegol, CDP870, Cimzia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 6 Jun 2006 (estimated)
- Results
- Posted 12 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 [NCT00308581]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Certolizumab pegol 400 mg | Experimental | Biological: Certolizumab pegol (CDP870)400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having completed study C87042 [NCT00308581] (previously treated with infliximab)
Key exclusion criteria (4 listed)
- Subject withdraw from C87042 [NCT00308581] study
- Subject who received treatment other than certolizumab pegol and other than medications permitted in C87042 [NCT00308581] study
- Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment
- Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration
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 pegol (CDP870)Also: CDP870, Cimzia400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks | Biological | Certolizumab pegol 400 mg |
Primary outcome
Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
Time frame: Maximum 164 weeks
Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.
23 secondary outcomes
Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).
Time frame: Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Time frame: Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Time frame: Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Time frame: Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]
Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study
Time frame: Maximum 154 weeks
Occurrence of at Least 1 Hospital Stay During the Treatment Period
Time frame: Maximum 152 weeks
Occurrence of at Least 1 Hospital Stay During the Follow-Up Period
Time frame: Maximum 12 weeks
Occurrence of at Least 1 Hospital Stay During the During the Overall Period
Time frame: Maximum 164 weeks
Length of Hospital Stays During the Treatment Period
Time frame: Maximum 152 weeks
Length of Hospital Stays During the Follow-Up Period
Time frame: Maximum 12 weeks
Length of Hospital Stays During the Overall Period
Time frame: Maximum 164 weeks
Occurrence of at Least 1 Emergency Room Visit During the Treatment Period
Time frame: Maximum 152 weeks
Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period
Time frame: Maximum 12 weeks
Occurrence of at Least 1 Emergency Room Visit During the Overall Period
Time frame: Maximum 164 weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period
Time frame: Maximum 152 weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period
Time frame: Maximum 12 weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period
Time frame: Maximum 164 weeks
Occurrence of at Least 1 General Concomitant Medication During the Treatment Period
Time frame: Maximum 152 weeks
Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period
Time frame: Maximum 12 weeks
Occurrence of at Least 1 General Concomitant Medication During the Overall Period
Time frame: Maximum 164 weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.
Time frame: Maximum 152 weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period
Time frame: Maximum 12 weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period
Time frame: Maximum 164 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
65 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Certolizumab pegol (CDP870) in people with Crohn's Disease, run by UCB Pharma at 65 sites in 12 countries.
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 1 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: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Germany, Belgium, Italy, Canada and 7 more countries. 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 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?
Yes. Results are posted in the registry (first posted 12 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks) (time frame: Maximum 164 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 7 Aug 2018.