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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00175877




Registration number
NCT00175877
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
26/03/2020

Titles & IDs
Public title
A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis
Scientific title
A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis
Secondary ID [1] 0 0
2005-001350-24
Secondary ID [2] 0 0
C87028
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Other - Certolizumab Pegol

Experimental: Certolizumab Pegol - All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.


Treatment: Other: Certolizumab Pegol
Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.

Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.

Duration: Until end of study.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
Timepoint [1] 0 0
From first dose of CZP to the end of the open-label study (approximately 7 years)
Primary outcome [2] 0 0
Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
Timepoint [2] 0 0
From first dose of CZP to the end of the open-label study (approximately 7 years)
Primary outcome [3] 0 0
Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study
Timepoint [3] 0 0
From Entry Visit (Week 0) to the end of the study (approximately 6.5 years)
Secondary outcome [1] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48
Timepoint [1] 0 0
From Baseline of the preceding double-blind study to Week 48 of the open-label study
Secondary outcome [2] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96
Timepoint [2] 0 0
From Baseline of the preceding double-blind study to Week 96 of the open-label study
Secondary outcome [3] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144
Timepoint [3] 0 0
From Baseline of the preceding double-blind study to Week 144 of the open-label study
Secondary outcome [4] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192
Timepoint [4] 0 0
From Baseline of the preceding double-blind study to Week 192 of the open-label study
Secondary outcome [5] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240
Timepoint [5] 0 0
From Baseline of the preceding double-blind study to Week 240 of the open-label study
Secondary outcome [6] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal
Timepoint [6] 0 0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary outcome [7] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48
Timepoint [7] 0 0
From Baseline of the preceding double-blind study to Week 48 of the open-label study
Secondary outcome [8] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96
Timepoint [8] 0 0
From Baseline of the preceding double-blind study to Week 96 of the open-label study
Secondary outcome [9] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144
Timepoint [9] 0 0
From Baseline of the preceding double-blind study to Week 144 of the open-label study
Secondary outcome [10] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192
Timepoint [10] 0 0
From Baseline of the preceding double-blind study to Week 192 of the open-label study
Secondary outcome [11] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240
Timepoint [11] 0 0
From Baseline of the preceding double-blind study to Week 240 of the open-label study
Secondary outcome [12] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal
Timepoint [12] 0 0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary outcome [13] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48
Timepoint [13] 0 0
From Baseline of the preceding double-blind study to Week 48 of the open-label study
Secondary outcome [14] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96
Timepoint [14] 0 0
From Baseline of the preceding double-blind study to Week 96 of the open-label study
Secondary outcome [15] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144
Timepoint [15] 0 0
From Baseline of the preceding double-blind study to Week 144 of the open-label study
Secondary outcome [16] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192
Timepoint [16] 0 0
From Baseline of the preceding double-blind study to Week 192 of the open-label study
Secondary outcome [17] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240
Timepoint [17] 0 0
From Baseline of the preceding double-blind study to Week 240 of the open-label study
Secondary outcome [18] 0 0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal
Timepoint [18] 0 0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary outcome [19] 0 0
Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS)
Timepoint [19] 0 0
From Baseline of the preceding double-blind study to Week 96 of the open-label study
Secondary outcome [20] 0 0
Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score
Timepoint [20] 0 0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary outcome [21] 0 0
Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness
Timepoint [21] 0 0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary outcome [22] 0 0
Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])
Timepoint [22] 0 0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary outcome [23] 0 0
Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit
Timepoint [23] 0 0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary outcome [24] 0 0
Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score
Timepoint [24] 0 0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Secondary outcome [25] 0 0
Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score
Timepoint [25] 0 0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)

Eligibility
Key inclusion criteria
Patients must have either failed to achieve American College of Rheumatology 20 % Response Criteria (ACR20) at Weeks 12 and 14 in C87027 [NCT00152386], or must have completed the entire Week 52 assessment of C87027 [NCT00152386] trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or Ankylosing Spondylitis)
* A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis
* Any concomitant biological therapy
* Any experimental therapy, within or outside a clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
Accrual to date
Final
857
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
18 - Malvern
Recruitment hospital [2] 0 0
21 - Maroochydore
Recruitment hospital [3] 0 0
23 - Perth
Recruitment postcode(s) [1] 0 0
- Malvern
Recruitment postcode(s) [2] 0 0
- Maroochydore
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Capital Federal
Country [16] 0 0
Argentina
State/province [16] 0 0
Ciudad Autonoma de Buenos Aire
Country [17] 0 0
Argentina
State/province [17] 0 0
Cordoba
Country [18] 0 0
Argentina
State/province [18] 0 0
Quilmes
Country [19] 0 0
Argentina
State/province [19] 0 0
Rosario
Country [20] 0 0
Argentina
State/province [20] 0 0
San Miguel de Tucuman
Country [21] 0 0
Argentina
State/province [21] 0 0
Santa Fe
Country [22] 0 0
Belgium
State/province [22] 0 0
Antwerpen
Country [23] 0 0
Belgium
State/province [23] 0 0
Liege
Country [24] 0 0
Belgium
State/province [24] 0 0
Merksem
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Pleven
Country [26] 0 0
Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Canada
State/province [28] 0 0
Ontario
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Canada
State/province [29] 0 0
Hamilton
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Canada
State/province [30] 0 0
Kitchener
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Canada
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Pointe Claire
Country [32] 0 0
Canada
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Sainte Foy
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Canada
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Winnipeg
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Chile
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Santiago de Chile
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Chile
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Valdivia
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Croatia
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Rijeka
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Czechia
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Brno
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Czechia
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Ostrava Trebovice
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Czechia
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Plzen
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Czechia
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Praha 2
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Czechia
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Praha 5
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Czechia
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Praha
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Czechia
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Uherske Hradiste
Country [44] 0 0
Czechia
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Zlin
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Estonia
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Parnu
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Estonia
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Tallinn
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Estonia
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Tartu
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Finland
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Hyvinkaa
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France
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Montpellier Cedex 5
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Hungary
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Budapest
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Hungary
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Bupadest
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Hungary
State/province [52] 0 0
Debrecen
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Hungary
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Miskolc
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Hungary
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Szolnok
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Israel
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Afula
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Israel
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Ashkelon
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Israel
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Haifa
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Israel
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Zerifin
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Latvia
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Riga
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Lithuania
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Alytus
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Panevezys
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Lithuania
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Siauliai
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Lithuania
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Vilnius
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Mexico
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Mexicalli
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Mexico
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Monterrey
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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South Canterbury
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New Zealand
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Tauranga
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Russian Federation
State/province [74] 0 0
Moscow
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Russian Federation
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St. Petersburg
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Russian Federation
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Yaroslavl
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Serbia
State/province [77] 0 0
Belgrade
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Serbia
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Niska Banja
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Serbia
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Novi Sad
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Piestany
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Ukraine
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Dnepropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kiev
Country [87] 0 0
Ukraine
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Symferopyl
Country [88] 0 0
Ukraine
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Zaporozhye

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT00175877