Trial · NCT00552058
Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
NCT00552058, Phase 3, Completed, UCB Pharma; results first posted 2010-12-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease. Trials, record NCT00552058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00552058
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
- NCT number
- NCT00552058
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 439 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Crohn Disease
- Interventions
- certolizumab pegol (CDP870, CZP), Placebo
- First posted
- 2007-11-01
- Last updated
- 2018-08-09
- Other registries' IDs
- eudract:2007-001913-41
- Results first posted
- 2010-12-30
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects in Clinical Remission at Week 6 | Week 6 | The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. |
| Secondary | Percentage of Subjects Achieving a Clinical Response at Week 6 | Week 0, Week 6 | The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease. |
| Secondary | Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6 | Week 6 | The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life. |
| Secondary | Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6 | Week 0 to Week 6 | The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. |
| Secondary | Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6 | Week 0 to Week 6 | The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being. |
| Secondary | Percentage of Subjects in Clinical Remission at Week 2 | Week 2 | The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. |
| Secondary | Percentage of Subjects in Clinical Remission at Week 4 | Week 4 | The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. |
| Secondary | Percentage of Subjects Achieving a Clinical Response at Week 2 | Week 0, Week 2 | The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. |
| Secondary | Percentage of Subjects Achieving a Clinical Response at Week 4 | Week 0, Week 4 | The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. |
| Secondary | Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2 | Week 0 to Week 2 | The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects in Clinical Remission at Week 6 | Week 6 | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Achieving a Clinical Response at Week 6 | Week 0, Week 6 | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6 | Week 6 | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | percentage of subjects | NUMBER |
| SECONDARY | Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6 | Week 0 to Week 6 | Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 192 and 183 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | score on a scale | MEAN |
| SECONDARY | Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6 | Week 0 to Week 6 | Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 196 and 187 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | score on a scale | MEAN |
| SECONDARY | Percentage of Subjects in Clinical Remission at Week 2 | Week 2 | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects in Clinical Remission at Week 4 | Week 4 | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Achieving a Clinical Response at Week 2 | Week 0, Week 2 | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Achieving a Clinical Response at Week 4 | Week 0, Week 4 | Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | percentage of subjects | NUMBER |
| SECONDARY | Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2 | Week 0 to Week 2 | Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 204 and 198 subjects respectively are included in this summary and have assessments at both Weeks 0 and 2. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose. | score on a scale | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects in Clinical Remission at Week 6 | Certolizumab Pegol | 31.6 | 95% Confidence Interval 25.4 to 37.8 | percentage of subjects | |
| Percentage of Subjects in Clinical Remission at Week 6 | Placebo | 25.4 | 95% Confidence Interval 19.5 to 31.3 | percentage of subjects | |
| Percentage of Subjects Achieving a Clinical Response at Week 6 | Certolizumab Pegol | 40.5 | 95% Confidence Interval 33.9 to 47.0 | percentage of subjects | |
| Percentage of Subjects Achieving a Clinical Response at Week 6 | Placebo | 34.0 | 95% Confidence Interval 27.6 to 40.4 | percentage of subjects | |
| Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6 | Certolizumab Pegol | 36.7 | 95% Confidence Interval 30.3 to 43.2 | percentage of subjects | |
| Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6 | Placebo | 28.7 | 95% Confidence Interval 22.6 to 34.8 | percentage of subjects | |
| Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6 | Certolizumab Pegol | -96.7 | Standard Deviation 100.86 | score on a scale | |
| Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6 | Placebo | -73.1 | Standard Deviation 95.07 | score on a scale | |
| Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6 | Certolizumab Pegol | -3.3 | Standard Deviation 4.00 | score on a scale | |
| Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6 | Placebo | -2.6 | Standard Deviation 3.90 | score on a scale |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Certolizumab Pegol | 223 | |
| Overall Study | STARTED | Placebo | 216 | |
| Overall Study | COMPLETED | Certolizumab Pegol | 207 | |
| Overall Study | COMPLETED | Placebo | 192 | |
| Overall Study | NOT COMPLETED | Certolizumab Pegol | 16 | |
| Overall Study | NOT COMPLETED | Placebo | 24 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Certolizumab Pegol | 10 | 223 | 10 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Placebo | 8 | 215 | 8 |
| other | NAUSEA | Gastrointestinal disorders | Certolizumab Pegol | 9 | 223 | 9 |
| other | NAUSEA | Gastrointestinal disorders | Placebo | 10 | 215 | 11 |
| other | FATIGUE | General disorders | Certolizumab Pegol | 9 | 223 | 9 |
| other | FATIGUE | General disorders | Placebo | 2 | 215 | 2 |
| other | PYREXIA | General disorders | Certolizumab Pegol | 7 | 223 | 9 |
| other | PYREXIA | General disorders | Placebo | 10 | 215 | 14 |
| other | URINARY TRACT INFECTION | Infections and infestations | Certolizumab Pegol | 7 | 223 | 7 |
| other | URINARY TRACT INFECTION | Infections and infestations | Placebo | 5 | 215 | 5 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Certolizumab Pegol | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Certolizumab Pegol | 48 | 223 |
| Total, other adverse events | Placebo | 42 | 215 |
| Total, serious adverse events | Certolizumab Pegol | 12 | 223 |
| Total, serious adverse events | Placebo | 8 | 215 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Certolizumab Pegol vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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