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Rheumatoid ArthritisPhase 3NCT00152386

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

A Phase 3 study testing Certolizumab pegol (CDP870) in people with Rheumatoid Arthritis, run by UCB Pharma at 76 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Certolizumab pegol (CDP870)
How many people
950 participants
Where
76 sitesin 13 countries
Study dates
Feb 2005to Oct 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • ≥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to attend for a Week 52 X-ray of the hands and feet even if they are no longer receiving study treatment but have not withdrawn their informed consent.

Who cannot join

  • 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).

Trial locations and contacts

76 sites in 13 countries.

76 sites in 13 countries

United States26 sites

  • Study site

    Austin, Texas

  • Study site

    Aventura, Florida

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Cleveland, Ohio

  • Study site

    Coeur d'Alene, Idaho

  • Study site

    Dallas, Texas

  • Study site

    Danbury, Connecticut

  • Study site

    Dayton, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Huntsville, Alabama

  • Study site

    La Jolla, California

  • Study site

    Lincoln, Nebraska

  • Study site

    Ocala, Florida

  • Study site

    Orlando, Florida

  • Study site

    Paradise Valley, Arizona

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Sarasota, Florida

  • Study site

    Springfield, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wheaton, Maryland

  • Study site

    Wichita, Kansas

Other trials in United States

Canada11 sites

  • Study site

    Courtice

  • Study site

    Hamilton

  • Study site

    Kitchener

  • Study site

    London

  • Study site

    Mississauga

  • Study site

    Montreal

  • Study site

    Newmarket

  • Study site

    Point Claire

  • Study site

    Sainte-Foy

  • Study site

    Toronto

  • Study site

    Winnipeg

Other trials in Canada

Australia8 sites

  • Study site

    Camperdown

  • Study site

    Coffs Harbour

  • Study site

    Cotton Tree

  • Study site

    Malvern

  • Study site

    Shenton Park

  • Study site

    Victoria Park

  • Study site

    Westmead

  • Study site

    Wooloongabba

Other trials in Australia

Czechia7 sites

  • Study site

    Brno

  • Study site

    Brno-Bohunice

  • Study site

    Ostrava Trebovice

  • Study site

    Pilsen

  • Study site

    Prague

  • Study site

    Uherské Hradiště

  • Study site

    Zlín

Other trials in Czechia

Belgium5 sites

  • Study site

    Antwerp

  • Study site

    Brussels

  • Study site

    Liège

  • Study site

    Merksem

  • Study site

    Sijsele

Other trials in Belgium

Bulgaria4 sites

  • Study site

    Pleven

  • Study site

    Sofia

  • Study site

    Stara Zagora

  • Study site

    Varna

Other trials in Bulgaria

Chile4 sites

  • Study site

    Santiago, Santiago Centro

  • Study site

    Santiago

  • Study site

    Temuco

  • Study site

    Valdivia, Las Condes

Other trials in Chile

Israel4 sites

  • Study site

    Afula

  • Study site

    Haifa

  • Study site

    Ramat Gan

  • Study site

    Tel Aviv

Other trials in Israel

Argentina2 sites

  • Study site

    Capital Federal

  • Study site

    Córdoba

Other trials in Argentina

Russia2 sites

  • Study site

    Moscow

  • Study site

    Saint Petersburg

Other trials in Russia

Croatia1 site

  • Study site

    Rijeka

Other trials in Croatia

Latvia1 site

  • Study site

    Riga

Other trials in Latvia

Ukraine1 site

  • Study site

    Ivano-Frankivsk

Other trials in Ukraine

About this study

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

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

Being tested
Certolizumab pegol (CDP870)
Keywords
Rheumatoid Arthritis, CDP870, Certolizumab pegol, Cimzia
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Certolizumab pegol (CDP870)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionOct 2006
  4. Study completionOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
950 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00152386
Sponsor's protocol ID
C87027
Other IDs
2004-002993-49, 2004
Status last verified
Nov 2020
First submitted
7 Sep 2005
Last updated
1 Dec 2020
Results posted
No

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.

    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.

    PubMed 19877104

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Certolizumab pegol (CDP870) in people with Rheumatoid Arthritis, run by UCB Pharma at 76 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Canada, Australia, Czechia, Belgium and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00152386, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.

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