Trial · NCT01550003
Pediatric Arthritis Study of Certolizumab Pegol
NCT01550003, Phase 3, Completed, UCB BIOSCIENCES GmbH; results first posted 2024-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pediatric Arthritis Study of Certolizumab Pegol. Trials, record NCT01550003. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01550003
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pediatric Arthritis Study of Certolizumab Pegol
- NCT number
- NCT01550003
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 193 participants, actual
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Conditions
- Polyarticular-course Juvenile Idiopathic Arthritis (JIA)
- Interventions
- Certolizumab Pegol (CZP), Certolizumab Pegol (CZP)
- First posted
- 2012-03-09
- Last updated
- 2026-09-25
- Results first posted
- 2024-10-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | Week 16 | Certolizumab Pegol (CZP) plasma concentration level was measured in micrograms per milliliter (ug/ml). |
| Primary | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48 | Week 48 | Certolizumab Pegol (CZP) plasma concentration level was measured in ug/mL. |
| Primary | Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16 | Week 16 | Number of participants with anti-CZP antibodies were reported. |
| Primary | Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48 | Week 48 | Number of participants with anti-CZP antibodies were reported. |
| Primary | Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study | From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years) | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in deaths, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect and other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication. |
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of the Investigational Medicinal Product (IMP) During the Study | From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years) | An AE is any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication. TEAEs leading to permanent withdrawal of the IMP during the study were reported in this outcome measure. |
| Secondary | Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16 | Week 16 | PedACR30-at least 30% improvement from baseline in 3 of any 6 core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment of Disease Activity (using visual analog scale (VAS): 100mm; 0= very good, and 100= very poor) * CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * C-reactive protein (CRP) |
| Secondary | Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16 | Week 16 | PedACR50- at least 50% improvement from baseline in 3 of any 6 core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment (PGA) of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor) * Childhood Health Assessment Questionnaire (CHAQ) (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * CRP |
| Secondary | Percentage of Participants Meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16 | Week 16 | PedACR70- at least 70% improvement from baseline in 3 of any 6 following core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor) * CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * CRP |
| Secondary | Percentage of Participants Meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16 | Week 16 | PedACR90- at least 90% improvement from baseline in 3 of any 6 following core set measures, with no more than 1 of remaining variables worsening by \>30%: * Number of joints with active arthritis * Number of joints with limitation of range of motion * Physician's Global Assessment of Disease Activity (using VAS: 100mm; 0= very good, and 100= very poor) * CHAQ (30 questions, 8 domains, scores for each domain are averaged to calculate total score \[ 0= no disability to 3= very severe disability\]) * Parent's Global Assessment of Overall Well-Being (using VAS: 100mm; 0= Very well to 100= Very poor) * CRP |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | Week 16 | The Pharmacokinetic Per-Protocol (PK-PP) Set was a subset of the SS consisting of those study participants who took at least 1 dose of study medication, provided measurable plasma CZP concentration samples (with recorded sampling date/time or for which date/time can be reasonably assumed). Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure. | ug/ml | GEOMETRIC_MEAN |
| PRIMARY | Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48 | Week 48 | The Pharmacokinetic Per-Protocol (PK-PP) Set was a subset of the SS consisting of those study participants who took at least 1 dose of study medication, provided measurable plasma CZP concentration samples (with recorded sampling date/time or for which date/time can be reasonably assumed). Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure. | ug/ml | GEOMETRIC_MEAN |
| PRIMARY | Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16 | Week 16 | Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48 | Week 48 | Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study | From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years) | Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of the Investigational Medicinal Product (IMP) During the Study | From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years) | Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Meeting American College of Rheumatology Pediatric 30 % (PedACR30) Response Criteria at Week 16 | Week 16 | Full analysis set (FAS): all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, Physician's Global Assessment of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Meeting American College of Rheumatology Pediatric 50 % (PedACR50) Response Criteria at Week 16 | Week 16 | FAS:all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, PGA of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Meeting American College of Rheumatology Pediatric 70 % (PedACR70) Response Criteria at Week 16 | Week 16 | FAS consisted of all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, Physician's Global Assessment of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Meeting American College of Rheumatology Pediatric 90 % (PedACR90) Response Criteria at Week 16 | Week 16 | FAS consisted of all study participants in SS who have no more than one of 6 core components missing at baseline (count of joints with active arthritis, count of joints with limitation of range of motion, Physician's Global Assessment of Disease Activity score, CHAQ score, Parent's Global Assessment of Overall Well-Being score and CRP result) for calculating PedACR30/50/70/90. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | Reduced CZP Dose -Weight Group: 10 - <20 kg | 1.6166 | 95% Confidence Interval 0.4720 to 5.5368 | ug/ml | |
| Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | Reduced CZP Dose - Weight Group: 20 - <40 kg | 9.2277 | 95% Confidence Interval 5.1453 to 16.5491 | ug/ml | |
| Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | Reduced CZP Dose - Weight Group: >=40 kg | 13.8928 | 95% Confidence Interval 11.0030 to 17.5416 | ug/ml | |
| Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | Original CZP Dose - Weight Group: 10 - <20 kg | 22.9060 | 95% Confidence Interval 13.3380 to 39.3374 | ug/ml | |
| Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | Original CZP Dose - Weight Group: 20 - <40 kg | 25.7752 | 95% Confidence Interval 16.9024 to 39.3058 | ug/ml | |
| Certolizumab Pegol (CZP) Plasma Concentration Level at Week 16 | Original CZP Dose - Weight Group: >=40 kg | 33.5680 | 95% Confidence Interval 25.7883 to 43.6945 | ug/ml | |
| Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48 | Reduced CZP Dose -Weight Group: 10 - <20 kg | 4.7404 | 95% Confidence Interval 1.7596 to 12.7710 | ug/ml | |
| Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48 | Reduced CZP Dose - Weight Group: 20 - <40 kg | 8.4459 | 95% Confidence Interval 5.0002 to 14.2661 | ug/ml | |
| Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48 | Reduced CZP Dose - Weight Group: >=40 kg | 12.2987 | 95% Confidence Interval 8.6950 to 17.3962 | ug/ml | |
| Certolizumab Pegol (CZP) Plasma Concentration Level at Week 48 | Original CZP Dose - Weight Group: 10 - <20 kg | NA | 95% Confidence Interval NA to NA | ug/ml |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Any CZP Dose - Weight Group: 10 - < 20 kg | 18 | |
| Overall Study | STARTED | Any CZP Dose - Weight Group: 20 - <40 kg | 63 | |
| Overall Study | STARTED | Any CZP Dose - Weight Group: >= 40 kg | 112 | |
| Overall Study | Original CZP Dose | Any CZP Dose - Weight Group: 10 - < 20 kg | 7 | |
| Overall Study | Original CZP Dose | Any CZP Dose - Weight Group: 20 - <40 kg | 34 | |
| Overall Study | Original CZP Dose | Any CZP Dose - Weight Group: >= 40 kg | 64 | |
| Overall Study | Reduced CZP Dose | Any CZP Dose - Weight Group: 10 - < 20 kg | 11 | |
| Overall Study | Reduced CZP Dose | Any CZP Dose - Weight Group: 20 - <40 kg | 29 | |
| Overall Study | Reduced CZP Dose | Any CZP Dose - Weight Group: >= 40 kg | 48 | |
| Overall Study | COMPLETED | Any CZP Dose - Weight Group: 10 - < 20 kg | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events423
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 | Lymphadenopathy | Blood and lymphatic system disorders | Any CZP Dose - Weight Group: 10 - <20 kg | 0 | 18 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Any CZP Dose - Weight Group: 20 - <40 kg | 5 | 63 | 6 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Any CZP Dose - Weight Group: >=40 kg | 4 | 112 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | Any CZP Dose - Weight Group: 10 - <20 kg | 1 | 18 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Any CZP Dose - Weight Group: 20 - <40 kg | 4 | 63 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Any CZP Dose - Weight Group: >=40 kg | 3 | 112 | 7 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Any CZP Dose - Weight Group: 10 - <20 kg | 1 | 18 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Any CZP Dose - Weight Group: 20 - <40 kg | 0 | 63 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Any CZP Dose - Weight Group: >=40 kg | 1 | 112 | 1 |
| other | Lichen spinulosus | Congenital, familial and genetic disorders | Any CZP Dose - Weight Group: 10 - <20 kg | 1 | 18 | 1 |
1 to 10 of 423Source ClinicalTrials.gov
See all 423 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Any CZP Dose - Weight Group: 10 - <20 kg | 0 | 18 |
| Total, all-cause mortality | Any CZP Dose - Weight Group: 20 - <40 kg | 0 | 63 |
| Total, all-cause mortality | Any CZP Dose - Weight Group: >=40 kg | 3 | 112 |
| Total, other adverse events | Any CZP Dose - Weight Group: 10 - <20 kg | 16 | 18 |
| Total, other adverse events | Any CZP Dose - Weight Group: 20 - <40 kg | 59 | 63 |
| Total, other adverse events | Any CZP Dose - Weight Group: >=40 kg | 98 | 112 |
| Total, serious adverse events | Any CZP Dose - Weight Group: 10 - <20 kg | 5 | 18 |
| Total, serious adverse events | Any CZP Dose - Weight Group: 20 - <40 kg | 20 | 63 |
| Total, serious adverse events | Any CZP Dose - Weight Group: >=40 kg | 21 | 112 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42439289 | RESULT |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Reduced CZP Dose vs Original CZP Dose: Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 48 | Trial comparisons |
| Reduced CZP Dose vs Original CZP Dose: Number of Participants With Anti-Certolizumab Pegol (Anti-CZP) Antibody Level at Week 16 | 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01550003
GET https://conductscience.org/api/trials/v1/NCT01550003/results?page=2