A Phase 3 interventional study of Certolizumab Pegol (CDP870) in Crohn's Disease, sponsored by UCB Pharma SA. Completed at 141 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by UCB Pharma SA · Phase 3, Interventional, and Treatment
A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an exacerbation of Crohn's Disease.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 310 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →UCB Pharma SA is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] clinical studies in which the subject completed the Week 2 assessment in CDP870-031 [NCT00152490] or the Week 6 randomization in CDP870-032 [NCT00152425] but whose Crohn's Disease was significantly worse as determined by the investigator and whose Clinical Disease Activity Index (CDAI) score at entry to this study is either (subjects may have received active or placebo treatment):
Exclusion Criteria:
3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.
Biological: Certolizumab Pegol (CDP870)
Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360. Up to 84 months of therapy in this study.
Also known as: Cimzia, CDP870, CZP
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months)
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months)
An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.
Time frame: Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit
HBI remission is defined as total HBI score of 4 points or less. 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 (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
Time frame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032
Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. 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 (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
Time frame: From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months)
Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034
Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. 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 (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
Time frame: From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months)
Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit
Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
Time frame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034
Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] to the last Visit in this study. A positive result is defined as Anti-CZP antibody levels \> 2.4 units/mL.
Time frame: From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months)
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
Time frame: Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256
Time frame: Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256
This multicenter study started to enroll subjects in February 2004 in order to end up with 141 centers in 24 countries with enrolled subjects. Participant Flow refers to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
| Milestone | Certolizumab Pegol |
|---|---|
| Started | 310 |
| Completed | 24 |
| Not completed | 286 |
| Withdrew: Adverse event | 53 |
| Withdrew: Adverse event and other reason | 105 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Withdrawal by subject | 41 |
| Withdrew: Withdrawal by subject and other | 12 |
| Withdrew: Physician decision | 10 |
| Withdrew: Physician decision and other | 3 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Lost to follow-up and other | 1 |
| Withdrew: Lack of efficacy | 42 |
| Withdrew: Lack of efficacy and other | 1 |
| Withdrew: Other reason | 11 |
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
| percentage of subjects | Certolizumab Pegol |
|---|---|
| Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months) | 94.2 |
An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.
| percentage of subjects | Certolizumab Pegol |
|---|---|
| Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months) | 44.5 |
HBI remission is defined as total HBI score of 4 points or less. 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 (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
| percentage of subjects | Certolizumab Pegol |
|---|---|
| Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit | 34.6 (29.3 to 39.9) |
Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. 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 (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
| percentage of subjects | Certolizumab Pegol |
|---|---|
| Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032 | 52.8 (47.2 to 58.4) |
Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. 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 (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
| percentage of subjects | Certolizumab Pegol |
|---|---|
| Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034 | 65.6 (60.2 to 70.9) |
Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
| µg/mL | Certolizumab Pegol |
|---|---|
| Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit | 5.870 (4.915 to 7.009) |
Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] to the last Visit in this study. A positive result is defined as Anti-CZP antibody levels \> 2.4 units/mL.
| percentage of subjects | Certolizumab Pegol |
|---|---|
| Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034 | 23.6 |
| mg/L | Certolizumab Pegol |
|---|---|
| C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit | 10.78 (9.28 to 12.53) |
| µg/g stool | Certolizumab Pegol |
|---|---|
| Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256 | 460.784 (382.149 to 555.599) |
Collected over Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 372).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Certolizumab Pegol | — | 138/310 (44.5%) | 248/310 (80%) |
| Event | Certolizumab Pegol |
|---|---|
| Crohn's diseaseGastrointestinal disorders | 49/310 |
| Perianal abscessInfections and infestations | 9/310 |
| Abdominal painGastrointestinal disorders | 8/310 |
| Small intestinal obstructionGastrointestinal disorders | 7/310 |
| AnaemiaBlood and lymphatic system disorders | 5/310 |
| Abdominal abscessInfections and infestations | 4/310 |
| SepsisInfections and infestations | 4/310 |
| PyrexiaGeneral disorders | 3/310 |
| FistulaMusculoskeletal and connective tissue disorders | 3/310 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/310 |
| Event | Certolizumab Pegol |
|---|---|
| Crohn's diseaseGastrointestinal disorders | 107/310 |
| Abdominal painGastrointestinal disorders | 62/310 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 49/310 |
| HeadacheNervous system disorders | 48/310 |
| NasopharyngitisInfections and infestations | 44/310 |
| DiarrhoeaGastrointestinal disorders | 41/310 |
| NauseaGastrointestinal disorders | 40/310 |
| Urinary tract infectionInfections and infestations | 36/310 |
| InfluenzaInfections and infestations | 34/310 |
| Upper respiratory tract infectionInfections and infestations | 34/310 |
Baseline Characteristics refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
| Age, Categorical(Participants) | Certolizumab Pegol |
|---|---|
| <=18 years | 2 |
| Between 18 and 65 years | 299 |
| >=65 years | 9 |
| Age, Continuous(years) | Certolizumab Pegol |
|---|---|
| Mean | 36.5 ± 11.67 |
| Sex: Female, Male(Participants) | Certolizumab Pegol |
|---|---|
| Female | 179 |
| Male | 131 |
| Region of Enrollment(participants) | Certolizumab Pegol |
|---|---|
| Serbia | 4 |
| United States | 74 |
| Belarus | 2 |
| Estonia | 5 |
| Slovenia | 3 |
| Spain | 1 |
| Ukraine | 3 |
| Austria | 7 |
| Russian Federation | 17 |
| Israel | 5 |
| Italy | 5 |
| Czech Republic | 10 |
| Hungary | 13 |
| Canada | 9 |
| Poland | 10 |
| Belgium | 8 |
| Singapore | 2 |
| Australia | 43 |
| Denmark | 11 |
| South Africa | 31 |
| Bulgaria | 1 |
| Norway | 7 |
| Germany | 29 |
| New Zealand | 10 |
Showing the first 100 of 141 sites across 24 countries.
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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