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A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Certolizumab pegol (CDP870)
Sponsored by
UCB Pharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, CDP870, Certolizumab pegol, Cimzia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female, aged at least 18 years old at the Screening visit. A clear chest X-ray within 3 months prior to Baseline visit. A diagnosis of adult-onset RA (of at least six months duration but not longer than 15 years prior to Screening) as defined by the 1987 American College of Rheumatology classification criteria. Active RA disease at Screening and Baseline as defined by: ≥9 tender joints. ≥9 swollen joints. and fulfilling 1 of the following 2 criteria: ≥30 mm/hour ESR (Westergren), or CRP >15 mg/L. Must have received a stable dose of MTX with or without folic acid for at least 3 months prior to Baseline visit. The minimum dose is 10 mg MTX weekly. Patient must be willing to attend for a Week 52 X-ray of the hands and feet even if they are no longer receiving study treatment but have not withdrawn their informed consent. 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. OA 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 RA. A history of an infected joint prosthesis at any time with prosthesis still in situ. Does not meet exclusionary concomitant medication criteria. A history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time. Patients at a high risk of infection in the Investigator's opinion (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections).

Sites / Locations

Outcomes

Primary Outcome Measures

To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline

Secondary Outcome Measures

Change from Baseline in mTSS at week 24, Change from Baseline in HAQ-DI at weeks 24 and 52, ACR20 responder rate at week 52, ACR50 and ACR70 responder rate at weeks 24 and 52

Full Information

First Posted
September 7, 2005
Last Updated
November 26, 2020
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00152386
Brief Title
A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis
Official Title
A Phase III Multicentre, Double Blind, Placebo-controlled, Parallel Group 52-week Study to Assess the Efficacy and Safety of 2 Dose Regimens of Lyophilised CDP870 as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
UCB Pharma

4. Oversight

5. Study Description

Brief Summary
Patients will be assigned to one of three treatment groups. Study medication is administered over a 52 week study duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, CDP870, Certolizumab pegol, Cimzia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
950 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Certolizumab pegol (CDP870)
Primary Outcome Measure Information:
Title
To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline
Secondary Outcome Measure Information:
Title
Change from Baseline in mTSS at week 24, Change from Baseline in HAQ-DI at weeks 24 and 52, ACR20 responder rate at week 52, ACR50 and ACR70 responder rate at weeks 24 and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female, aged at least 18 years old at the Screening visit. A clear chest X-ray within 3 months prior to Baseline visit. A diagnosis of adult-onset RA (of at least six months duration but not longer than 15 years prior to Screening) as defined by the 1987 American College of Rheumatology classification criteria. Active RA disease at Screening and Baseline as defined by: ≥9 tender joints. ≥9 swollen joints. and fulfilling 1 of the following 2 criteria: ≥30 mm/hour ESR (Westergren), or CRP >15 mg/L. Must have received a stable dose of MTX with or without folic acid for at least 3 months prior to Baseline visit. The minimum dose is 10 mg MTX weekly. Patient must be willing to attend for a Week 52 X-ray of the hands and feet even if they are no longer receiving study treatment but have not withdrawn their informed consent. 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. OA 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 RA. A history of an infected joint prosthesis at any time with prosthesis still in situ. Does not meet exclusionary concomitant medication criteria. A history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time. Patients at a high risk of infection in the Investigator's opinion (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
Country
United States
City
Paradise Valley
State/Province
Arizona
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Danbury
State/Province
Connecticut
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Aventura
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Coeur d'Alene
State/Province
Idaho
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Wheaton
State/Province
Maryland
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Lincoln
State/Province
Nebraska
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Capital Federal
Country
Argentina
City
Cordoba
Country
Argentina
City
Camperdown
Country
Australia
City
Coffs Harbour
Country
Australia
City
Cotton Tree
Country
Australia
City
Malvern
Country
Australia
City
Shenton Park
Country
Australia
City
Victoria Park
Country
Australia
City
Westmead
Country
Australia
City
Wooloongabba
Country
Australia
City
Antwerpen
Country
Belgium
City
Brussels
Country
Belgium
City
Liege
Country
Belgium
City
Merksem
Country
Belgium
City
Sijsele
Country
Belgium
City
Pleven
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Stara Zagora
Country
Bulgaria
City
Varna
Country
Bulgaria
City
Courtice
Country
Canada
City
Hamilton
Country
Canada
City
Kitchener
Country
Canada
City
London
Country
Canada
City
Mississauga
Country
Canada
City
Montreal
Country
Canada
City
Newmarket
Country
Canada
City
Point Claire
Country
Canada
City
Sainte Foy
Country
Canada
City
Toronto
Country
Canada
City
Winnipeg
Country
Canada
City
Valdivia
State/Province
Las Condes
Country
Chile
City
Santiago
State/Province
Santiago Centro
Country
Chile
City
Santiago de Chile
Country
Chile
City
Santiago
Country
Chile
City
Temuco
Country
Chile
City
Rijeka
Country
Croatia
City
Brno Bohunice
Country
Czechia
City
Brno
Country
Czechia
City
Ostrava Trebovice
Country
Czechia
City
Plzen
Country
Czechia
City
Prague 2
Country
Czechia
City
Praha 5
Country
Czechia
City
Praha
Country
Czechia
City
Uherske Hradiste
Country
Czechia
City
Zlin
Country
Czechia
City
Afula
Country
Israel
City
Haifa
Country
Israel
City
Ramat Gan
Country
Israel
City
Tel Aviv
Country
Israel
City
Riga
Country
Latvia
City
Moscow
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Ivano-Frankivsk
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
18975346
Citation
Keystone E, Heijde Dv, Mason D Jr, Landewe R, Vollenhoven RV, Combe B, Emery P, Strand V, Mease P, Desai C, Pavelka K. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008 Nov;58(11):3319-29. doi: 10.1002/art.23964. Erratum In: Arthritis Rheum. 2009 May;60(5):1249.
Results Reference
result
PubMed Identifier
20799264
Citation
van Vollenhoven RF, Felson D, Strand V, Weinblatt ME, Luijtens K, Keystone EC. American College of Rheumatology hybrid analysis of certolizumab pegol plus methotrexate in patients with active rheumatoid arthritis: data from a 52-week phase III trial. Arthritis Care Res (Hoboken). 2011 Jan;63(1):128-34. doi: 10.1002/acr.20331.
Results Reference
result
PubMed Identifier
20547658
Citation
Hazes JM, Taylor P, Strand V, Purcaru O, Coteur G, Mease P. Physical function improvements and relief from fatigue and pain are associated with increased productivity at work and at home in rheumatoid arthritis patients treated with certolizumab pegol. Rheumatology (Oxford). 2010 Oct;49(10):1900-10. doi: 10.1093/rheumatology/keq109. Epub 2010 Jun 14.
Results Reference
result
PubMed Identifier
21485024
Citation
Pincus T, Furer V, Keystone E, Yazici Y, Bergman MJ, Luijtens K. RAPID3 (Routine Assessment of Patient Index Data 3) severity categories and response criteria: Similar results to DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) in the RAPID 1 (Rheumatoid Arthritis Prevention of Structural Damage) clinical trial of certolizumab pegol. Arthritis Care Res (Hoboken). 2011 Aug;63(8):1142-9. doi: 10.1002/acr.20481.
Results Reference
result
PubMed Identifier
21484766
Citation
Curtis JR, Chen L, Luijtens K, Navarro-Millan I, Goel N, Gervitz L, Weinblatt M. Dose escalation of certolizumab pegol from 200 mg to 400 mg every other week provides no additional efficacy in rheumatoid arthritis: an analysis of individual patient-level data. Arthritis Rheum. 2011 Aug;63(8):2203-8. doi: 10.1002/art.30387.
Results Reference
result
PubMed Identifier
21362764
Citation
Keystone EC, Curtis JR, Fleischmann RM, Furst DE, Khanna D, Smolen JS, Mease PJ, Schiff MH, Coteur G, Davies O, Combe B. Rapid improvement in the signs and symptoms of rheumatoid arthritis following certolizumab pegol treatment predicts better longterm outcomes: post-hoc analysis of a randomized controlled trial. J Rheumatol. 2011 Jun;38(6):990-6. doi: 10.3899/jrheum.100935. Epub 2011 Mar 1.
Results Reference
result
PubMed Identifier
22231904
Citation
Curtis JR, Luijtens K, Kavanaugh A. Predicting future response to certolizumab pegol in rheumatoid arthritis patients: features at 12 weeks associated with low disease activity at 1 year. Arthritis Care Res (Hoboken). 2012 May;64(5):658-67. doi: 10.1002/acr.21600.
Results Reference
result
PubMed Identifier
32100960
Citation
Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1.
Results Reference
result
PubMed Identifier
29246162
Citation
Curtis JR, Winthrop K, O'Brien C, Ndlovu MN, de Longueville M, Haraoui B. Use of a baseline risk score to identify the risk of serious infectious events in patients with rheumatoid arthritis during certolizumab pegol treatment. Arthritis Res Ther. 2017 Dec 15;19(1):276. doi: 10.1186/s13075-017-1466-y.
Results Reference
derived
PubMed Identifier
26238672
Citation
Combe B, Furst DE, Keystone EC, van der Heijde D, Luijtens K, Ionescu L, Goel N, Emery P. Certolizumab Pegol Efficacy Across Methotrexate Regimens: A Pre-Specified Analysis of Two Phase III Trials. Arthritis Care Res (Hoboken). 2016 Mar;68(3):299-307. doi: 10.1002/acr.22676.
Results Reference
derived
PubMed Identifier
22589265
Citation
van der Heijde D, Keystone EC, Curtis JR, Landewe RB, Schiff MH, Khanna D, Kvien TK, Ionescu L, Gervitz LM, Davies OR, Luijtens K, Furst DE. Timing and magnitude of initial change in disease activity score 28 predicts the likelihood of achieving low disease activity at 1 year in rheumatoid arthritis patients treated with certolizumab pegol: a post-hoc analysis of the RAPID 1 trial. J Rheumatol. 2012 Jul;39(7):1326-33. doi: 10.3899/jrheum.111171. Epub 2012 May 15.
Results Reference
derived
PubMed Identifier
19909548
Citation
Strand V, Mease P, Burmester GR, Nikai E, Coteur G, van Vollenhoven R, Combe B, Keystone EC, Kavanaugh A. Rapid and sustained improvements in health-related quality of life, fatigue, and other patient-reported outcomes in rheumatoid arthritis patients treated with certolizumab pegol plus methotrexate over 1 year: results from the RAPID 1 randomized controlled trial. Arthritis Res Ther. 2009;11(6):R170. doi: 10.1186/ar2859. Epub 2009 Nov 12.
Results Reference
derived
PubMed Identifier
19877104
Citation
Kavanaugh A, Smolen JS, Emery P, Purcaru O, Keystone E, Richard L, Strand V, van Vollenhoven RF. Effect of certolizumab pegol with methotrexate on home and work place productivity and social activities in patients with active rheumatoid arthritis. Arthritis Rheum. 2009 Nov 15;61(11):1592-600. doi: 10.1002/art.24828. Erratum In: Arthritis Rheum. 2010 Oct;62(10):1514.
Results Reference
derived

Learn more about this trial

A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis

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