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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00152386




Registration number
NCT00152386
Ethics application status
Date submitted
7/09/2005
Date registered
9/09/2005
Date last updated
1/12/2020

Titles & IDs
Public title
A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis
Scientific 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
Secondary ID [1] 0 0
2004-002993-49
Secondary ID [2] 0 0
C87027
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
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0

Eligibility
Key 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.
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. 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Coffs Harbour
Recruitment hospital [3] 0 0
- Cotton Tree
Recruitment hospital [4] 0 0
- Malvern
Recruitment hospital [5] 0 0
- Shenton Park
Recruitment hospital [6] 0 0
- Victoria Park
Recruitment hospital [7] 0 0
- Westmead
Recruitment hospital [8] 0 0
- Wooloongabba
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Coffs Harbour
Recruitment postcode(s) [3] 0 0
- Cotton Tree
Recruitment postcode(s) [4] 0 0
- Malvern
Recruitment postcode(s) [5] 0 0
- Shenton Park
Recruitment postcode(s) [6] 0 0
- Victoria Park
Recruitment postcode(s) [7] 0 0
- Westmead
Recruitment postcode(s) [8] 0 0
- Wooloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
State/province [3] 0 0
California
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United States of America
State/province [4] 0 0
Colorado
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United States of America
State/province [5] 0 0
Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Kansas
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United States of America
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Maryland
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United States of America
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Missouri
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United States of America
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Nebraska
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Texas
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Argentina
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Capital Federal
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Argentina
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Cordoba
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Liege
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Belgium
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Merksem
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Belgium
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Sijsele
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Bulgaria
State/province [28] 0 0
Stara Zagora
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Bulgaria
State/province [29] 0 0
Varna
Country [30] 0 0
Canada
State/province [30] 0 0
Courtice
Country [31] 0 0
Canada
State/province [31] 0 0
Hamilton
Country [32] 0 0
Canada
State/province [32] 0 0
Kitchener
Country [33] 0 0
Canada
State/province [33] 0 0
London
Country [34] 0 0
Canada
State/province [34] 0 0
Mississauga
Country [35] 0 0
Canada
State/province [35] 0 0
Montreal
Country [36] 0 0
Canada
State/province [36] 0 0
Newmarket
Country [37] 0 0
Canada
State/province [37] 0 0
Point Claire
Country [38] 0 0
Canada
State/province [38] 0 0
Sainte Foy
Country [39] 0 0
Canada
State/province [39] 0 0
Toronto
Country [40] 0 0
Canada
State/province [40] 0 0
Winnipeg
Country [41] 0 0
Chile
State/province [41] 0 0
Las Condes
Country [42] 0 0
Chile
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Santiago Centro
Country [43] 0 0
Chile
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Santiago de Chile
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Chile
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Santiago
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Chile
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Temuco
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Croatia
State/province [46] 0 0
Rijeka
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Czechia
State/province [47] 0 0
Brno Bohunice
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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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Prague 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
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Czechia
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Zlin
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Israel
State/province [56] 0 0
Afula
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Israel
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Haifa
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Israel
State/province [58] 0 0
Ramat Gan
Country [59] 0 0
Israel
State/province [59] 0 0
Tel Aviv
Country [60] 0 0
Latvia
State/province [60] 0 0
Riga
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Moscow
Country [62] 0 0
Russian Federation
State/province [62] 0 0
St. Petersburg
Country [63] 0 0
Ukraine
State/province [63] 0 0
Ivano-Frankivsk

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

Ethics approval
Ethics application status

Summary
Brief summary
Patients will be assigned to one of three treatment groups. Study medication is administered over a 52 week study duration.
Trial website
https://clinicaltrials.gov/study/NCT00152386
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
UCB Pharma
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00152386