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

Arthritis, Psoriatic Clinical Trial

Official title:

Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Adult-Onset Active and Progressive Psoriatic Arthritis (PsA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087788
• Other study ID #: PsA001
• Secondary ID: 2009-011720-59
• Status: Completed
• Phase: Phase 3
• Start date: March 2010
• Est. completion date: August 2015

Study information

• Verified date: January 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset active and progressive Psoriatic Arthritis (PsA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: August 2015
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of adult-onset Psoriatic Arthritis (PsA) of at least 6 months' duration as defined by the Classification Criteria for Psoriatic Arthritis (CASPAR criteria)

• Active Psoriatic Skin Lesions or a documented history of Psoriasis

• Active Arthritis with = 3 tender joints at Screening and Baseline, = 3 swollen joints at Screening and Baseline and fulfilling at least 1 of the following 2 criteria during the Screening Period:

1. Erythrocyte Sedimentation Rate (ESR) (Westergren) = 28 mm/hour

2. C-reactive protein (CRP) > Upper Limit Normal (ULN)

• Failure to 1 or more treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Exclusion Criteria:

• Diagnosis of any other inflammatory Arthritis or known diagnosis of Fibromyalgia

• Exposure to more than 1 Tumor Necrosis Factor a (TNFa) antagonist or to more than 2 previous biological response modifiers for PsA or Psoriasis

• Any non-biological systemic treatment of Psoriasis; phototherapy; topical agents

• History of chronic or recurrent infections

• High risk of infection

• Live vaccination within the 8 weeks prior to Baseline

• Concurrent malignancy or a history of malignancy

• Class III or IV congestive Heart Failure - New York Heart Association (NYHA)

• Demyelinating disease of the central nervous system

• Clinically significant laboratory abnormalities

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Biological:
• CZP 200 mg Q2W
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
• CZP 400 mg Q4W
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).

Other:
• Placebo
Matching Placebo to CZP injection.

Locations

Country	Name	City	State
Argentina	700	Buenos Aires
Argentina	704	Buenos Aires
Argentina	707	Ciudad Autonoma de Buenos Aires
Argentina	705	Cordoba
Argentina	706	Rosario
Argentina	710	San Juan
Argentina	702	San Miguel De Tucuman
Argentina	708	San Miguel de Tucuman
Belgium	152	Gent
Belgium	151	Liege
Brazil	750	Curitiba
Brazil	761	Goiâna
Brazil	757	Goias
Brazil	753	Porto Alegre
Canada	900	St. John's	Newfoundland and Labrador
Canada	904	Toronto	Ontario
Canada	905	Trois-Rivires	Quebec
Canada	907	Victoria	British Columbia
Canada	910	Windsor	Ontario
Czechia	504	Brno
Czechia	501	Hlucin
Czechia	500	Pardubice
Czechia	502	Praha 2
Czechia	505	Terezin
Czechia	503	Zlin
France	206	Montpellier
France	204	Paris
France	202	Tours
Germany	252	Bad Nauheim
Germany	257	Berlin
Germany	258	Berlin
Germany	262	Frankfurt
Germany	255	Freiburg
Germany	254	Hamburg
Germany	253	Leipzig
Germany	263	München
Germany	256	Ratingen
Hungary	303	Budapest
Hungary	304	Budapest
Hungary	302	Debrecen
Hungary	301	Gyula
Hungary	306	Miskolc
Hungary	300	Veszprém
Ireland	100	Dublin 4
Italy	352	Ancona
Italy	350	Pisa
Mexico	802	Cuernavaca
Mexico	803	Mexico D.F.
Poland	458	Bialystok
Poland	452	Dabrowka
Poland	455	Elblag
Poland	459	Gdansk
Poland	457	Krakow
Poland	450	Lublin
Poland	454	Poznan
Poland	453	Torun
Poland	456	Warszawa
Poland	462	Warszawa
Spain	555	Madrid
Spain	550	Mérida
Spain	552	Santiago de Compostela
Spain	553	Sevilla
United Kingdom	605	Barnsley
United Kingdom	602	London
United Kingdom	601	Salford
United States	963	Asheville	North Carolina
United States	957	Aventura	Florida
United States	961	Birmingham	Alabama
United States	985	Brooklyn	New York
United States	976	Cleveland	Ohio
United States	975	Dallas	Texas
United States	972	Duncansville	Pennsylvania
United States	969	Eagan	Minnesota
United States	965	Florissant	Missouri
United States	984	Flowood	Mississippi
United States	962	Fort Lauderdale	Florida
United States	964	Hagerstown	Maryland
United States	978	Houston	Texas
United States	960	Kalamazoo	Michigan
United States	951	Middleburg Heights	Ohio
United States	970	Oklahoma City	Oklahoma
United States	959	Orange Park	Florida
United States	966	Palm Desert	California
United States	954	Peoria	Arizona
United States	982	Portland	Oregon
United States	950	Saint Louis	Missouri
United States	967	San Antonio	Texas
United States	952	San Diego	California
United States	971	Scottsdale	Arizona
United States	968	Seattle	Washington
United States	953	Tuscaloosa	Alabama
United States	958	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
UCB BIOSCIENCES GmbH

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Czechia,  France,  Germany,  Hungary,  Ireland,  Italy,  Mexico,  Poland,  Spain,  United Kingdom, 

References & Publications (3)

Mease PJ, Fleischmann R, Deodhar AA, Wollenhaupt J, Khraishi M, Kielar D, Woltering F, Stach C, Hoepken B, Arledge T, van der Heijde D. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 d — View Citation

van der Heijde D, Deodhar A, FitzGerald O, Fleischmann R, Gladman D, Gottlieb AB, Hoepken B, Bauer L, Irvin-Sellers O, Khraishi M, Peterson L, Turkiewicz A, Wollenhaupt J, Mease PJ. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled t — View Citation

van der Heijde D, Fleischmann R, Wollenhaupt J, Deodhar A, Kielar D, Woltering F, Stach C, Hoepken B, Arledge T, Mease PJ. Effect of different imputation approaches on the evaluation of radiographic progression in patients with psoriatic arthritis: result — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology 20 (ACR20) Response at 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).	Week 12
Primary	Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at 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.	From Baseline to Week 24
Secondary	American College of Rheumatology 20 (ACR20) Response at 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).	Week 24
Secondary	Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at 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.	From Baseline to Week 24
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	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.	Week 24
Secondary	Change From Baseline in Modified Total Sharp Score (mTSS) at 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.	From Baseline to Week 48

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