Trial · NCT02552212
Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS
NCT02552212, Phase 3, Completed, UCB BIOSCIENCES GmbH; results first posted 2020-08-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS. Trials, record NCT02552212. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02552212
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS
- NCT number
- NCT02552212
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 317 participants, actual
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Conditions
- Axial Spondyloarthritis, Nonradiographic Axial Spondyloarthritis, Nr-axSpA
- Interventions
- Certolizumab Pegol, Placebo
- First posted
- 2015-09-17
- Last updated
- 2022-08-18
- Other registries' IDs
- eudract:2015-001894-41
- Results first posted
- 2020-08-17
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52 | Week 52 | This variable was considered as primary in all countries except for Canada (and any other country where applicable or where requested by Regulatory Authorities) where it was considered as secondary variable. ASDAS-MI was achieved when there was a reduction (improvement) \>= 2.0 in the ASDAS relative to Baseline, or when the lowest possible ASDAS score (0.6) was reached. The ASDAS was calculated as the sum of the following components: 0.121 × Back pain (BASDAI Q2 result) 0.058 × Duration of morning stiffness (BASDAI Q6 result) 0.110 × Patient's Global Assessment of Disease Activity (PGADA) 0.073 × Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm \[ln\] of the (CRP \[mg/L\] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units, where 0 is "not active" and 10 is "very active"). |
| Primary | Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12 | Week 12 | This variable was considered as primary for Canada (and any other country where applicable or where requested by Regulatory Authorities) and as secondary variable in all other countries. The ASAS40 response was defined as relative improvements of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. |
| Primary | Certolizumab Pegol Plasma Concentration at Baseline | Baseline (Week 0) | Certolizumab pegol plasma concentration was measured at Baseline in micrograms per millilitre (µg/mL). |
| Primary | Certolizumab Pegol Plasma Concentration at Week 1 | Week 1 | Certolizumab pegol plasma concentration was measured at Week 1, in µg/mL. |
| Primary | Certolizumab Pegol Plasma Concentration at Week 2 | Week 2 | Certolizumab pegol plasma concentration was measured at Week 2, in µg/mL. |
| Primary | Certolizumab Pegol Plasma Concentration at Week 4 | Week 4 | Certolizumab pegol plasma concentration was measured at Week 4, in µg/mL. |
| Primary | Certolizumab Pegol Plasma Concentration at Week 12 | Week 12 | Certolizumab pegol plasma concentration was measured at Week 12, in µg/mL. |
| Primary | Certolizumab Pegol Plasma Concentration at Week 24 | Week 24 | Certolizumab pegol plasma concentration was measured at Week 24, in µg/mL. |
| Primary | Certolizumab Pegol Plasma Concentration at Week 36 | Week 36 | Certolizumab pegol plasma concentration was measured at Week 36, in µg/mL. |
| Primary | Certolizumab Pegol Plasma Concentration at Week 52 | Week 52 | Certolizumab pegol plasma concentration was measured at Week 52, in µg/mL. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52 | Week 52 | The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12 | Week 12 | The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication. | percentage of subjects | NUMBER |
| PRIMARY | Certolizumab Pegol Plasma Concentration at Baseline | Baseline (Week 0) | The Safety Set (SS) consisted of all subjects who have received at least 1 dose of study medication. Note: None of the Safety Set subjects had Pharmacokinetic (PK) concentrations above the lower limit of quantification. | ||
| PRIMARY | Certolizumab Pegol Plasma Concentration at Week 1 | Week 1 | The SS consisted of all subjects who received at least 1 dose of study treatment. Note: No samples taken at Week 1 for the Placebo-\>OL CZP. | µg/mL | GEOMETRIC_MEAN |
| PRIMARY | Certolizumab Pegol Plasma Concentration at Week 2 | Week 2 | The SS consisted of all subjects who received at least 1 dose of study treatment. Note: No samples taken at Week 2 for the Placebo-\>OL CZP. | µg/mL | GEOMETRIC_MEAN |
| PRIMARY | Certolizumab Pegol Plasma Concentration at Week 4 | Week 4 | The SS consisted of all subjects who received at least 1 dose of study treatment. | µg/mL | GEOMETRIC_MEAN |
| PRIMARY | Certolizumab Pegol Plasma Concentration at Week 12 | Week 12 | The SS consisted of all subjects who received at least 1 dose of study treatment. | µg/mL | GEOMETRIC_MEAN |
| PRIMARY | Certolizumab Pegol Plasma Concentration at Week 24 | Week 24 | The SS consisted of all subjects who received at least 1 dose of study treatment. | µg/mL | GEOMETRIC_MEAN |
| PRIMARY | Certolizumab Pegol Plasma Concentration at Week 36 | Week 36 | The SS consisted of all subjects who received at least 1 dose of study treatment. | µg/mL | GEOMETRIC_MEAN |
| PRIMARY | Certolizumab Pegol Plasma Concentration at Week 52 | Week 52 | The SS consisted of all subjects who received at least 1 dose of study treatment. Note: No samples taken at OL Week 52 for the Placebo-\>OL CZP. | µg/mL | GEOMETRIC_MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52 | Placebo (FAS) | 7.0 | percentage of subjects | ||
| Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52 | CZP 200 mg Q2W (FAS) | 47.2 | percentage of subjects | ||
| Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12 | Placebo (FAS) | 11.4 | percentage of subjects | ||
| Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12 | CZP 200 mg Q2W (FAS) | 47.8 | percentage of subjects | ||
| Certolizumab Pegol Plasma Concentration at Week 1 | CZP 200 mg Q2W (SS) | 50.5 | 95% Confidence Interval 48.0 to 53.0 | µg/mL | |
| Certolizumab Pegol Plasma Concentration at Week 2 | CZP 200 mg Q2W (SS) | 36.4 | 95% Confidence Interval 33.0 to 40.1 | µg/mL | |
| Certolizumab Pegol Plasma Concentration at Week 4 | CZP 200 mg Q2W (SS) | 54.6 | 95% Confidence Interval 51.4 to 58.0 | µg/mL | |
| Certolizumab Pegol Plasma Concentration at Week 4 | Placebo->OL CZP (SS) | 48.8 | 95% Confidence Interval 42.2 to 56.4 | µg/mL | |
| Certolizumab Pegol Plasma Concentration at Week 12 | CZP 200 mg Q2W (SS) | 29.1 | 95% Confidence Interval 24.0 to 35.2 | µg/mL | |
| Certolizumab Pegol Plasma Concentration at Week 12 | Placebo->OL CZP (SS) | 30.5 | 95% Confidence Interval 26.4 to 35.3 | µg/mL |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Period (Week 0 - 52) | STARTED | Placebo | 158 | |
| Double-Blind Period (Week 0 - 52) | STARTED | CZP 200 mg Q2W | 159 | |
| Double-Blind Period (Week 0 - 52) | STARTED | SFE OL CZP 200 mg Q2W | 0 | |
| Double-Blind Period (Week 0 - 52) | Received OL CZP | Placebo | 96 | |
| Double-Blind Period (Week 0 - 52) | Received OL CZP | CZP 200 mg Q2W | 20 | |
| Double-Blind Period (Week 0 - 52) | Received OL CZP | SFE OL CZP 200 mg Q2W | 0 | |
| Double-Blind Period (Week 0 - 52) | Completed Week 52 Without Starting SFE | Placebo | 20 | |
| Double-Blind Period (Week 0 - 52) | Completed Week 52 Without Starting SFE | CZP 200 mg Q2W | 22 | |
| Double-Blind Period (Week 0 - 52) | Completed Week 52 Without Starting SFE | SFE OL CZP 200 mg Q2W | 0 | |
| Double-Blind Period (Week 0 - 52) | COMPLETED | Placebo | 143 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events225
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 | Diarrhoea | Gastrointestinal disorders | Placebo (SS) | 10 | 158 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | CZP 200 mg Q2W (SS) | 8 | 159 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo->OL CZP (SS) | 1 | 96 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | CZP->OL CZP (SS) | 0 | 20 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | SFE OL CZP 200 mg Q2W (SS) | 4 | 243 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo (SS) | 16 | 158 | 23 |
| other | Upper respiratory tract infection | Infections and infestations | CZP 200 mg Q2W (SS) | 30 | 159 | 38 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo->OL CZP (SS) | 10 | 96 | 14 |
| other | Upper respiratory tract infection | Infections and infestations | CZP->OL CZP (SS) | 4 | 20 | 5 |
| other | Upper respiratory tract infection | Infections and infestations | SFE OL CZP 200 mg Q2W (SS) | 21 | 243 | 31 |
1 to 10 of 225Source ClinicalTrials.gov
See all 225 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (SS) | 0 | 158 |
| Total, all-cause mortality | CZP 200 mg Q2W (SS) | 0 | 159 |
| Total, all-cause mortality | Placebo->OL CZP (SS) | 0 | 96 |
| Total, all-cause mortality | CZP->OL CZP (SS) | 0 | 20 |
| Total, all-cause mortality | SFE OL CZP 200 mg Q2W (SS) | 0 | 243 |
| Total, other adverse events | Placebo (SS) | 59 | 158 |
| Total, other adverse events | CZP 200 mg Q2W (SS) | 75 | 159 |
| Total, other adverse events | Placebo->OL CZP (SS) | 27 | 96 |
| Total, other adverse events | CZP->OL CZP (SS) | 7 | 20 |
| Total, other adverse events | SFE OL CZP 200 mg Q2W (SS) | 69 | 243 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CZP 200 mg Q2W (FAS) vs Placebo (FAS): Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52 | Trial comparisons |
| CZP 200 mg Q2W (FAS) vs Placebo (FAS): Number of Subjects Without Relevant Changes to Background Medication From Baseline to Week 52 | 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/NCT02552212
GET https://conductscience.org/api/trials/v1/NCT02552212/registered?page=2