Trial · NCT01087788

Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis

NCT01087788, Phase 3, Completed, UCB BIOSCIENCES GmbH; results first posted 2014-02-25

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis. Trials, record NCT01087788. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01087788

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis
NCT number: NCT01087788
Status: Completed
Phases: Phase 3
Enrollment: 409 participants, actual
Lead sponsor: UCB BIOSCIENCES GmbH
Conditions: Arthritis, Psoriatic
Interventions: CZP 200 mg Q2W, CZP 400 mg Q4W, Placebo
First posted: 2010-03-16
Last updated: 2018-08-01
Other registries' IDs: eudract:2009-011720-59
Results first posted: 2014-02-25

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	American College of Rheumatology 20 (ACR20) Response at Week 12	Week 12	ACR20 responders are those subjects with at least 20 % improvement from Baseline (BL) for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).
Primary	Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24	From Baseline to Week 24	Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome). For the pre-defined analysis of this outcome measure, 0 was used for Baseline and the maximum observed mTSS value was used for Week 24 for those subjects which had less than 2 radiographs. The re-analysis is restricted to those subjects in the Randomized Set who have at least 2 x-ray values at scheduled visits, which are at least 8 weeks apart.
Secondary	American College of Rheumatology 20 (ACR20) Response at Week 24	Week 24	ACR20 responders are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).
Secondary	Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24	From Baseline to Week 24	The HAQ-DI is a measure of function in Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline. The higher the negative value, the higher the improvement.
Secondary	Psoriasis Area Severity Index (PASI75) Response at Week 24 in the Subgroup of Subjects With Psoriasis (PSO) Involving at Least 3 % Body Surface Area (BSA) at Baseline	Week 24	The PASI75 response assessments are based on at least 75 % improvement in the PASI score from Baseline. The PASI score is a measure of the average redness, thickness, and scaliness of the psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement.
Secondary	Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48	From Baseline to Week 48	Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome). For the analysis of this outcome measure, the change from Baseline to Week 48 was imputed using the median change from Baseline among all subjects for those subjects, which had less than 2 radiographs. The post-hoc analysis presented here is based on the subgroup of subjects which had a Baseline mTSS value greater than 6.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	American College of Rheumatology 20 (ACR20) Response at Week 12	Week 12	Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.	percentage of participants	NUMBER
PRIMARY	Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24	From Baseline to Week 24	Intention-to-treat dataset was the Randomized Set (RS). RS with imputation: for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, scores are linearly extrapolated from the last two radiographs prior to early withdrawal or Week 24 or before receiving CZP.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	American College of Rheumatology 20 (ACR20) Response at Week 24	Week 24	Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24	From Baseline to Week 24	Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Psoriasis Area Severity Index (PASI75) Response at Week 24 in the Subgroup of Subjects With Psoriasis (PSO) Involving at Least 3 % Body Surface Area (BSA) at Baseline	Week 24	Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48	From Baseline to Week 48	Randomized Set (RS) with imputation: for subjects who withdrew for any reason, or subjects with missing Week 48 measurements, and for all placebo subjects after the switch to CZP, Week 48 scores are linearly extrapolated from the last two available radiographs prior to early withdrawal or Week 24 or before receiving CZP.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
American College of Rheumatology 20 (ACR20) Response at Week 12	Placebo (Randomized Set)		24.3	95% Confidence Interval 17.1 to 31.5	percentage of participants
American College of Rheumatology 20 (ACR20) Response at Week 12	CZP 200 mg Q2W (Randomized Set)		58.0	95% Confidence Interval 49.7 to 66.2	percentage of participants
American College of Rheumatology 20 (ACR20) Response at Week 12	CZP 400 mg Q4W (Randomized Set)		51.9	95% Confidence Interval 43.4 to 60.3	percentage of participants
Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24	Placebo (Randomized Set)	Pre-defined results	28.92	95% Confidence Interval 13.73 to 44.11	units on a scale
Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24	CZP 200 mg Q2W (Randomized Set)	Pre-defined results	11.52	95% Confidence Interval -3.40 to 26.45	units on a scale
Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24	CZP 400 mg Q4W (Randomized Set)	Pre-defined results	25.05	95% Confidence Interval 9.48 to 40.61	units on a scale
Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24	CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)	Pre-defined results	18.28	95% Confidence Interval 6.34 to 30.23	units on a scale
Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24	Placebo (Randomized Set)	Re-analysis results ( n = 123, 130, 123, 253)	0.18	95% Confidence Interval 0.04 to 0.33	units on a scale
Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24	CZP 200 mg Q2W (Randomized Set)	Re-analysis results ( n = 123, 130, 123, 253)	-0.02	95% Confidence Interval -0.16 to 0.11	units on a scale
Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24	CZP 400 mg Q4W (Randomized Set)	Re-analysis results ( n = 123, 130, 123, 253)	0.09	95% Confidence Interval -0.05 to 0.23	units on a scale

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow39

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
24-weeks Double-blind Period	STARTED	Placebo	136
24-weeks Double-blind Period	STARTED	CZP 200 mg Q2W	138
24-weeks Double-blind Period	STARTED	CZP 400 mg Q4W	135
24-weeks Double-blind Period	Received CZP 200 mg Q2W at 16 Weeks	Placebo	30
24-weeks Double-blind Period	Received CZP 200 mg Q2W at 16 Weeks	CZP 200 mg Q2W	0
24-weeks Double-blind Period	Received CZP 200 mg Q2W at 16 Weeks	CZP 400 mg Q4W	0
24-weeks Double-blind Period	Received CZP 400 mg Q4W at 16 Weeks	Placebo	29
24-weeks Double-blind Period	Received CZP 400 mg Q4W at 16 Weeks	CZP 200 mg Q2W	0
24-weeks Double-blind Period	Received CZP 400 mg Q4W at 16 Weeks	CZP 400 mg Q4W	0
24-weeks Double-blind Period	COMPLETED	Placebo	120

1 to 10 of 39Source ClinicalTrials.gov

See all 39 participant flow

Adverse events414

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	All CZP 200 mg Q2W	15	198	20
other	Diarrhoea	Gastrointestinal disorders	All CZP 400 mg Q4W	11	195	15
other	Diarrhoea	Gastrointestinal disorders	All CZP 200 mg + 400 mg	26	393	35
other	Abdominal pain	Gastrointestinal disorders	All CZP 200 mg Q2W	12	198	13
other	Abdominal pain	Gastrointestinal disorders	All CZP 400 mg Q4W	9	195	10
other	Abdominal pain	Gastrointestinal disorders	All CZP 200 mg + 400 mg	21	393	23
other	Abdominal pain upper	Gastrointestinal disorders	All CZP 200 mg Q2W	14	198	16
other	Abdominal pain upper	Gastrointestinal disorders	All CZP 400 mg Q4W	5	195	9
other	Abdominal pain upper	Gastrointestinal disorders	All CZP 200 mg + 400 mg	19	393	25
other	Nausea	Gastrointestinal disorders	All CZP 200 mg Q2W	10	198	11

1 to 10 of 414Source ClinicalTrials.gov

See all 414 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	All CZP 200 mg Q2W
Total, all-cause mortality	All CZP 400 mg Q4W
Total, all-cause mortality	All CZP 200 mg + 400 mg
Total, other adverse events	All CZP 200 mg Q2W	158	198
Total, other adverse events	All CZP 400 mg Q4W	153	195
Total, other adverse events	All CZP 200 mg + 400 mg	311	393
Total, serious adverse events	All CZP 200 mg Q2W	49	198
Total, serious adverse events	All CZP 400 mg Q4W	51	195
Total, serious adverse events	All CZP 200 mg + 400 mg	100	393

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23942868	RESULT	PubMed
23942869	RESULT	PubMed
24339179	DERIVED	PubMed
24942382	DERIVED	PubMed
24996416	DERIVED	PubMed
27696727	DERIVED	PubMed
29556416	RESULT	PubMed
30191421	DERIVED	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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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