CClinicalTrials.gg
CompletedNCT00152386Updated Dec 1, 2020

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

A Phase 3 interventional study of Certolizumab pegol (CDP870) in Rheumatoid Arthritis, sponsored by UCB Pharma. Completed at 79 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-01.

Sponsored by UCB Pharma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
950
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid Arthritis, CDP870
  • Certolizumab pegol, Cimzia
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 950 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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to attend for a Week 52 X-ray of the hands and feet even if they are no longer receiving study treatment but have not withdrawn their informed consent.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

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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
950 participants

Interventions

  • DrugCertolizumab pegol (CDP870)
06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

07

Study locations

79 sites
  • Huntsville, Alabama, United States
  • Paradise Valley, Arizona, United States
  • La Jolla, California, United States
  • San Diego, California, United States
  • Denver, Colorado, United States
  • Danbury, Connecticut, United States
  • Washington, District of Columbia, United States
  • Aventura, Florida, United States
  • Ocala, Florida, United States
  • Orlando, Florida, United States
  • Sarasota, Florida, United States
  • Tampa, Florida, United States
  • Coeur d'Alene, Idaho, United States
  • Springfield, Illinois, United States
  • Wichita, Kansas, United States
  • Wheaton, Maryland, United States
  • Saint Louis, Missouri, United States
  • Lincoln, Nebraska, United States
  • Charlotte, North Carolina, United States
  • Cleveland, Ohio, United States
  • Dayton, Ohio, United States
  • Duncansville, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • San Antonio, Texas, United States
  • Capital Federal, Argentina
  • Cordoba, Argentina
  • Camperdown, Australia
  • Coffs Harbour, Australia
  • Cotton Tree, Australia
  • Malvern, Australia
  • Shenton Park, Australia
  • Victoria Park, Australia
  • Westmead, Australia
  • Wooloongabba, Australia
  • Antwerpen, Belgium
  • Brussels, Belgium
  • Liege, Belgium
  • Merksem, Belgium
  • Sijsele, Belgium
  • Pleven, Bulgaria
  • Sofia, Bulgaria
  • Stara Zagora, Bulgaria
  • Varna, Bulgaria
  • Courtice, Canada
  • Hamilton, Canada
  • Kitchener, Canada
  • London, Canada
  • Mississauga, Canada
  • Montreal, Canada
  • Newmarket, Canada
  • Point Claire, Canada
  • Sainte Foy, Canada
  • Toronto, Canada
  • Winnipeg, Canada
  • Valdivia, Las Condes, Chile
  • Santiago, Santiago Centro, Chile
  • Santiago de Chile, Chile
  • Santiago, Chile
  • Temuco, Chile
  • Rijeka, Croatia
  • Brno Bohunice, Czechia
  • Brno, Czechia
  • Ostrava Trebovice, Czechia
  • Plzen, Czechia
  • Prague 2, Czechia
  • Praha 5, Czechia
  • Praha, Czechia
  • Uherske Hradiste, Czechia
  • Zlin, Czechia
  • Afula, Israel
  • Haifa, Israel
  • Ramat Gan, Israel
  • Tel Aviv, Israel
  • Riga, Latvia
  • Moscow, Russian Federation
  • St. Petersburg, Russian Federation
  • Ivano-Frankivsk, Ukraine
08

References and documents

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. PubMed 18975346 ↗
  • 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. PubMed 20799264 ↗
  • 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. PubMed 20547658 ↗
  • 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. PubMed 21485024 ↗
  • 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. PubMed 21484766 ↗
  • 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. PubMed 21362764 ↗
  • 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. PubMed 22231904 ↗
  • 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. PubMed 32100960 ↗
  • 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. PubMed 29246162 ↗
  • 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. PubMed 26238672 ↗
  • 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. PubMed 22589265 ↗
  • 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. PubMed 19909548 ↗
  • 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. PubMed 19877104 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00152386
Lead sponsor
UCB Pharma
First posted
Sep 9, 2005
Start date
Feb 2005
Primary completion
Oct 2006
Completion
Oct 2006
Last update
Dec 1, 2020

Study contacts

UCB Clinical Trial Call Center
study director · UCB Pharma
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion