Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

A Phase 2 study testing Certolizumab Pegol in people with Crohn's Disease, run by UCB Pharma at 22 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease. Read more about this study

Who is it for?: Ages 16 to 65 years
Conditions the study is for: Crohn's Disease
What is being tested?: Certolizumab Pegol
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 94 participants
Where: 22 sitesJapan
Study dates: 2 Mar 2006to 8 Nov 2007
Phase: Phase 2
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 16 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients who are diagnosed with Crohn's disease (according to the Crohn's disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders [Shimoyama group, January 25, 2002]) at least 24 weeks before the starting date of the observation period
Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period
C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period

Who cannot join

Stoma patient
Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody
Patients who participated in a clinical study with CDP870
Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period
Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

Japan22 sites

Study site
Aichi-Gun, Aichi-ken
Study site
Asahikawa, Hokkaido
Study site
Chikusino, Fukuoka
Study site
Fukuoka
Study site
Kagoshima
Study site
Kashiwa, Chiba
Study site
Kurashiki, Okayama-ken
Study site
Miyazaki-gun, Miyazaki
Study site
Nagasaki
Study site
Nagoya, Aichi-ken
Study site
Niigata
Study site
Nishinomiya, Hyōgo
Study site
Osaka
Study site
Ōtsu, Shiga
Study site
Sakura, Chiba
Study site
Sapporo, Hokkaido
Study site
Shinjyuku, Tokyo
Study site
Suita, Osaka
Study site
Toyoake, Aichi-ken
Study site
Toyohashi, Aichi-ken
Study site
Tyuto-gun, Okinawa
Study site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease

This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.

Conditions: Crohn's Disease
Being tested: Certolizumab Pegol, Placebo
Keywords: Crohn's Disease, CDP870, 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 CDP870
- Active Substance: Certolizumab Pegol
- Pharmaceutical Form: Solution for injection in pre-filled syringe
- Concentration: 200 mg/mL
- Route of Administration: Subcutaneous use
PlaceboOther
- Active Substance: isotonic sodium chloride solution
- Pharmaceutical Form: Solution for injection
- Concentration: 1 mL
- Route of Administration: Subcutaneous use

Study groups in NCT00291668
Study group	Role	What they receive
Certolizumab pegol 200 mg	Experimental	Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4. Receives: Biological: Certolizumab Pegol; Other: Placebo
Certolizumab pegol 400 mg	Experimental	Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4. Receives: Biological: Certolizumab Pegol
Placebo	Placebo comparator	Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6
CDAI Response is presented as the percentage of subjects with clinical response at Week 6 or remission at Week 6. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0). Remission is defined as a CDAI of <= 150 at Week 6.
Measured: Baseline, Week 6

Secondary outcomes (26)

Crohn's Disease Activity Index (CDAI) Score at Week 2
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Week 2
Crohn's Disease Activity Index (CDAI) Score at Week 4
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Week 4
Crohn's Disease Activity Index (CDAI) Score at Week 6
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Week 6
Percentage of Subjects Who Achieve CDAI Response at Week 2
CDAI Response at Week 2 is defined as clinical response at Week 2 or remission at Week 2. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0). Remission is defined as a CDAI score of <= 150 points.
Measured: Baseline, Week 2
Percentage of Subjects Who Achieve CDAI Response at Week 4
CDAI Response at Week 4 is defined as clinical response at Week 4 or remission at Week 4. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0). Remission is defined as a CDAI score of <= 150 points.
Measured: Baseline, Week 4
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Baseline, Week 2
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Baseline, Week 4
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Baseline, Week 6
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2
Remission at Week 2 is defined as a CDAI score <= 150 points at Week 2.
Measured: Week 2
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4
Remission at Week 4 is defined as a CDAI score <= 150 points at Week 4.
Measured: Week 4
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6
Remission at Week 6 is defined as a CDAI score <= 150 points at Week 6.
Measured: Week 6
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) - (CDAI score at Week 0).
Measured: Baseline, Week 2
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) - (CDAI score at Week 0).
Measured: Baseline, Week 4
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6
Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0).
Measured: Baseline, Week 6
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Measured: Week 2
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Measured: Week 4
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6
The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
Measured: Week 6
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.
There are 4 IBDQ Domain Scores:
- Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)
- Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
- Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)
- Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Measured: Week 2
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.
There are 4 IBDQ Domain Scores:
- Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)
- Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
- Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)
- Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Measured: Week 4
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6
The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life.
There are 4 IBDQ Domain Scores:
- Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7)
- Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
- Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7)
- Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
Measured: Week 6
Concentration of C-reactive Protein (CRP) Value at Week 2
CRP data for subjects receiving rescue medication were excluded.
Measured: Week 2
Concentration of C-reactive Protein (CRP) Value at Week 4
CRP data for subjects receiving rescue medication were excluded.
Measured: Week 4
Concentration of C-reactive Protein (CRP) Value at Week 6
CRP data for subjects receiving rescue medication were excluded.
Measured: Week 6
C-reactive Protein (CRP) Ratio to Baseline at Week 2
CRP data for subjects receiving rescue medication were excluded.
Measured: Baseline, Week 2
C-reactive Protein (CRP) Ratio to Baseline at Week 4
CRP data for subjects receiving rescue medication were excluded.
Measured: Baseline, Week 4
C-reactive Protein (CRP) Ratio to Baseline at Week 6
CRP data for subjects receiving rescue medication were excluded.
Measured: Baseline, Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 20068 Nov 2007

First posted14 Feb 2006 (estimated)
Study start2 Mar 2006
Primary completion8 Nov 2007
Study completion8 Nov 2007

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00291668
Sponsor's protocol ID: C87037
Other IDs: 2014-004399-42, 2014
Status last verified: Jul 2020
First submitted: 10 Feb 2006
Last updated: 3 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease
ClinicalTrials.gov ID: NCT00291668
Acronym / sponsor ID: C87037
Conditions: Crohn's Disease
Keywords: Crohn's Disease, CDP870, Certolizumab pegol
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: 2 Mar 2006 (actual)
Primary completion: 8 Nov 2007 (actual)
Study completion: 8 Nov 2007 (actual)
First posted: 14 Feb 2006 (estimated)
Results: Posted 3 Aug 2020

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 multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Certolizumab pegol 200 mg	Experimental	Biological: Certolizumab Pegol, Other: PlaceboSubjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.
Certolizumab pegol 400 mg	Experimental	Biological: Certolizumab PegolSubjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
Placebo	Placebo comparator	Other: PlaceboSubjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.

Who may qualify

Ages: 16 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Patients who are diagnosed with Crohn's disease (according to the Crohn's disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders [Shimoyama group, January 25, 2002]) at least 24 weeks before the starting date of the observation period
Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period
C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period

Key exclusion criteria (5 listed)

Stoma patient
Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody
Patients who participated in a clinical study with CDP870
Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period
Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators

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: CDP870* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 200 mg/mL * Route of Administration: Subcutaneous use	Biological	Certolizumab pegol 200 mg, Certolizumab pegol 400 mg
Placebo* Active Substance: isotonic sodium chloride solution * Pharmaceutical Form: Solution for injection * Concentration: 1 mL * Route of Administration: Subcutaneous use	Other	Certolizumab pegol 200 mg, Placebo

Primary outcome

Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6
Time frame: Baseline, Week 6
CDAI Response is presented as the percentage of subjects with clinical response at Week 6 or remission at Week 6. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) - (CDAI score at Week 0). Remission is defined as a CDAI of <= 150 at Week 6.

26 secondary outcomes

Crohn's Disease Activity Index (CDAI) Score at Week 2
Time frame: Week 2
Crohn's Disease Activity Index (CDAI) Score at Week 4
Time frame: Week 4
Crohn's Disease Activity Index (CDAI) Score at Week 6
Time frame: Week 6
Percentage of Subjects Who Achieve CDAI Response at Week 2
Time frame: Baseline, Week 2
Percentage of Subjects Who Achieve CDAI Response at Week 4
Time frame: Baseline, Week 4
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 2
Time frame: Baseline, Week 2
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 4
Time frame: Baseline, Week 4
Percentage of Subjects Who Achieve a Reduction in CDAI Scores of at Least 70 Points at Week 6
Time frame: Baseline, Week 6
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 2
Time frame: Week 2
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 4
Time frame: Week 4
Percentage of Subjects Who Achieve Remission (CDAI <= 150) at Week 6
Time frame: Week 6
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 2
Time frame: Baseline, Week 2
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 4
Time frame: Baseline, Week 4
Percentage of Subjects Who Achieve Clinical Response (Reduction in CDAI Scores of at Least 100 Points) at Week 6
Time frame: Baseline, Week 6
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 2
Time frame: Week 2
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 4
Time frame: Week 4
Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 6
Time frame: Week 6
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 2
Time frame: Week 2
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 4
Time frame: Week 4
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 6
Time frame: Week 6
Concentration of C-reactive Protein (CRP) Value at Week 2
Time frame: Week 2
Concentration of C-reactive Protein (CRP) Value at Week 4
Time frame: Week 4
Concentration of C-reactive Protein (CRP) Value at Week 6
Time frame: Week 6
C-reactive Protein (CRP) Ratio to Baseline at Week 2
Time frame: Baseline, Week 2
C-reactive Protein (CRP) Ratio to Baseline at Week 4
Time frame: Baseline, Week 4
C-reactive Protein (CRP) Ratio to Baseline at Week 6
Time frame: Baseline, Week 6

Results and safety

Results posted to the registry on 3 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	32	28
Certolizumab Pegol 200 mg	30	29
Certolizumab Pegol 400 mg	32	31

Primary outcome: Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6

Time frame: Baseline, Week 6. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Full Analysis Set (Placebo Treated Subjects) n = 32	Full Analysis Set (CZP 200 mg Treated Subjects) n = 30	Full Analysis Set (CZP 400 mg Treated Subjects) n = 31
Value	25.0 (10.0 to 40.0)	43.3 (25.6 to 61.1)	48.4 (30.8 to 66.0)

Population analysed: Full Analysis Set defined as subjects randomized and allocated to study medication, excluding the following subjects determined by data review prior to unblinding: Subjects * with Good Clinical Practice (GCP) violations * who were not diagnosed (definitely) with CD * who received no dose of study medication * with no data after randomization

26 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from the time of signing the informed consent through the last Observation (up to 28 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 32 (9.4%)	16 of 32 (50%)	0 of 32
Certolizumab Pegol 200 mg	1 of 30 (3.3%)	11 of 30 (36.7%)	0 of 30
Certolizumab Pegol 400 mg	3 of 32 (9.4%)	14 of 32 (43.8%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Crohn's Disease

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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.

The record lists no contact. Use the official record to reach the sponsor.

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Certolizumab Pegol in people with Crohn's Disease, run by UCB Pharma at 22 sites in Japan.

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 3 inclusion and 5 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 3 Aug 2020). 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?

Crohn's Disease Activity Index (CDAI) Response (Clinical Response or Remission) at Week 6 (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00291668.

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 3 Aug 2020.