Clinical trial NCT00717236: Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis
Official title: A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Certolizumab pegol
Cimzia
Rheumatoid Arthritis
Joint Disease
Chronic Arthritis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-07-17
Enrollment: 1648
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.

Detailed description: The treatment period starts with a 12-week, double-blind, placebo-controlled, randomized period followed by an open-label extension phase. In the double-blind phase, eligible patients are randomized (4:1 ratio) to receive either certolizumab pegol (CZP) or Placebo up to and including Week 10. The randomization will be stratified according to the three factors: concomitant use of methotrexate (MTX, Yes or No), prior anti-tumor necrosis factor (anti-TNF) use (Yes or No), and disease duration categories (\< 2 years or ≥ 2 years). From Week 12 all patients remaining in the study receive open-label CZP for a minimum 16 additional weeks until CZP is commercially available.

Eligibility criteria: Inclusion Criteria:

* Adult patient with established moderate to severe rheumatoid arthritis

Exclusion Criteria:

* All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials

Primary outcomes:
measure: American College of Rheumatology 20% (ACR20) Response at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use.
timeFrame: Baseline, Week 12
measure: American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use.
timeFrame: Baseline, Week 12
measure: American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use
timeFrame: Baseline, Week 12
measure: American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use
timeFrame: Baseline, Week 12
measure: American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years
timeFrame: Baseline, Week 12
measure: American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years.
timeFrame: Baseline, Week 12
measure: American College of Rheumatology 50% (ACR50) Response at Week 12
timeFrame: Baseline, Week 12
measure: American College of Rheumatology 70% (ACR70) Response at Week 12.
timeFrame: Baseline, Week 12
measure: Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12
timeFrame: Baseline, Week 12
measure: DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12
timeFrame: Week 12
measure: SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12
timeFrame: Week 12
measure: CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12
timeFrame: Week 12
measure: Change From Baseline in Tender Joint Count (TJC) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Swollen Joint Count (SJC) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in C-reactive Protein (CRP) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12
timeFrame: Baseline, Week 12
measure: Time to Sustained American College of Rheumatology 20% (ACR20) Response
timeFrame: Baseline up to Week 12
measure: European League Against Rheumatism (EULAR) Response at Week 12
timeFrame: Baseline, Week 12
measure: American College of Rheumatology 20% (ACR20) Response at Week 28
timeFrame: Baseline, Week 28
measure: American College of Rheumatology 50% (ACR50) Response at Week 28
timeFrame: Baseline, Week 28
measure: American College of Rheumatology 70% (ACR70) Response at Week 28
timeFrame: Baseline, Week 28
measure: Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28
timeFrame: Baseline, Week 28
measure: Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28
timeFrame: Baseline, Week 28
measure: Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28
timeFrame: Baseline, Week 28
measure: DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28
timeFrame: Week 28
measure: SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28
timeFrame: Week 28
measure: CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28
timeFrame: Week 28
measure: Change From Baseline in Tender Joint Count (TJC) at Week 28
timeFrame: Baseline, Week 28
measure: Change From Baseline in Swollen Joint Count (SJC) at Week 28
timeFrame: Baseline, Week 28
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28
timeFrame: Baseline, Week 28
measure: Change From Baseline in C-reactive Protein (CRP) at Week 28
timeFrame: Baseline, Week 28
measure: Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28
timeFrame: Baseline, Week 28
measure: Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28
timeFrame: Baseline, Week 28
measure: Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28
timeFrame: Baseline, Week 28
Other outcomes:
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city: Orlando
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city: South Miami
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city: Tampa
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city: Tavares
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city: Atlanta
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state: Georgia
city: Coeur d'Alene
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state: Idaho
city: Idaho Falls
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city: Maywood
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state: Illinois
city: Peoria
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city: Winnipeg
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state: Manitoba
city: St. John's
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state: Newfoundland and Labrador
city: Halifax
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state: Nova Scotia
city: Hamilton
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state: Ontario
city: Kitchener
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state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
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state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Rimouski
country: Canada
state: Quebec
city: Trois-Rivires
country: Canada
state: Quebec
city: Calgary
country: Canada
city: Mississauga
country: Canada
city: Newmarket
country: Canada
city: Sainte Foy
country: Canada
city: Amiens
country: France
city: Cahors
country: France
city: Corbeil Essonnes
country: France
city: Dreux
country: France
city: Lievin
country: France
city: Montpellier
country: France
city: Mulhouse
country: France
city: Nantes
country: France
city: Orleans
country: France
city: Paris
country: France
city: Pierre-Benite
country: France
city: Rennes
country: France
city: Saint Priest en Jarez
country: France
city: Bad Neuenahr
country: Germany
city: Baden
country: Germany
city: Berlin
country: Germany
city: Chemnitz
country: Germany
city: Dresden
country: Germany
city: Duisburg
country: Germany
city: Erfurt
country: Germany
city: Erlangen
country: Germany
city: Freiburg
country: Germany
city: Friedrichroda
country: Germany
city: Goslar
country: Germany
city: Hamburg
country: Germany
city: Hildesheim
country: Germany
city: Hoyerswerda
country: Germany
city: Jena
country: Germany
city: Kiel
country: Germany
city: Koln
country: Germany
city: Leipzig
country: Germany
city: Mainz
country: Germany
city: Munchen
country: Germany
city: Neuss
country: Germany
city: Osnabruck
country: Germany
city: Rostock
country: Germany
city: Wiesbaden
country: Germany
city: Zerbst
country: Germany
city: Bologna
country: Italy
city: Genova
country: Italy
city: Jesi
country: Italy
city: Modena
country: Italy
city: Palermo
country: Italy
city: Pisa
country: Italy
city: Prato
country: Italy
city: Siena
country: Italy
city: Udine
country: Italy
city: Apeldoorn
country: Netherlands
city: Arnhem
country: Netherlands
city: Den-Haag
country: Netherlands
city: Leiden
country: Netherlands
city: Barcelona
country: Spain
city: Coruna
country: Spain
city: La Laguna
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Oviedo
country: Spain
city: Pontevedra
country: Spain
city: Sabadell
country: Spain
city: Salamanca
country: Spain
city: Santander
country: Spain
city: Santiago de Compostela
country: Spain
city: Torrelavega
country: Spain
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Pope J, Bingham CO 3rd, Fleischmann RM, Dougados M, Massarotti EM, Wollenhaupt J, Duncan B, Coteur G, Weinblatt ME. Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity. Arthritis Res Ther. 2015 Nov 27;17:343. doi: 10.1186/s13075-015-0849-1.
citation: Weinblatt ME, Fleischmann R, van Vollenhoven RF, Emery P, Huizinga TW, Cutolo M, van der Heijde D, Duncan B, Davies O, Luijtens K, Dougados M. Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population. Arthritis Res Ther. 2015 Nov 15;17:325. doi: 10.1186/s13075-015-0841-9.
citation: Weinblatt ME, Fleischmann R, Huizinga TW, Emery P, Pope J, Massarotti EM, van Vollenhoven RF, Wollenhaupt J, Bingham CO 3rd, Duncan B, Goel N, Davies OR, Dougados M. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford). 2012 Dec;51(12):2204-14. doi: 10.1093/rheumatology/kes150. Epub 2012 Aug 25.