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Rheumatoid ArthritisPhase 3NCT00160602

A Study of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

A Phase 3 study testing Certolizumab Pegol in people with Rheumatoid Arthritis, run by UCB Pharma at 70 sites in 15 countries.

Completed

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

Official record
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Trial summary

A 24 week study in which patients are given study medication and assessed for signs and symptoms of rheumatoid arthritis. X-rays are performed to assess the progress of joint damage during the study. 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
How many people
590 participants
Where
70 sitesin 15 countries
Study dates
Jun 2005to Sep 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

  • Patients must be at least 18 years old at the screening visit.
  • Patients must have a diagnosis of adult-onset RA of at least six months duration but not longer than fifteen years as defined by the 1987 American College of Rheumatology classification criteria.
  • Patients must have active RA disease as defined by:
  • 9 tender joints at Screening and Baseline.
  • 9 swollen joints at Screening and Baseline. and fulfilling 1 of the following 2 criteria during the screening period:
  • 30 mm/hour ESR (Westergren), or CRP >15 mg/L.
  • Patients must have received treatment with MTX (with or without folic acid) for at least 6 months prior to the Baseline visit. The dose of MTX and route of administration must have been stable for at least 2 months prior to the baseline visit. The minimum stable dose of MTX allowed is 10 mg weekly.
  • Patients must be willing to complete an X-ray of the hands and feet 24 weeks after randomization even if they are no longer receiving study treatment in the present study, provided they have not withdrawn their informed consent.

Who cannot join

  • Patients must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
  • Patients must not have a secondary, non-inflammatory type of arthritis (e.g. OA or fibromyalgia)
  • Female patients who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug.
  • Patients with a history of tuberculosis or positive chest X-ray for tuberculosis or positive
  • Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and patients who are permanently bed ridden or wheelchair bound).
  • Patients with known human immunodeficiency virus (HIV) infection.
Show all 9Show fewer
  • Patients with an active malignancy of any type or a history of malignancy (except basal cell carcinoma of the skin that has been excised prior to study start).
  • Patients with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the trial.
  • Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).

Trial locations and contacts

70 sites in 15 countries.

70 sites in 15 countries

United States17 sites

  • Study site

    Canfield, Ohio

  • Study site

    Montgomery, Alabama

  • Study site

    Naples, Florida

  • Study site

    New Brunswick, New Jersey

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Palm Desert, California

  • Study site

    Palm Harbor, Florida

  • Study site

    Pasadena, California

  • Study site

    Rochester, New York

  • Study site

    San Antonio, Texas

  • Study site

    Santa Maria, California

  • Study site

    South Miami, Florida

  • Study site

    St Louis, Missouri

  • Study site

    Stratford, New Jersey

  • Study site

    Sun City West, Arizona

  • Study site

    Wynnewood, Pennsylvania

Other trials in United States

Czechia7 sites

  • Study site

    Brno

  • Study site

    Hlučín

  • Study site

    Ostrava-Poruba

  • Study site

    Prague

  • Study site

    Sokolov

  • Study site

    UherskeHradiste

  • Study site

    Zlín

Other trials in Czechia

Israel7 sites

  • Study site

    Afula

  • Study site

    Ashkelon

  • Study site

    Beer Yaakov

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Ramat Gan

  • Study site

    Rehovot

Other trials in Israel

Poland6 sites

  • Study site

    Bialystok

  • Study site

    Elblag

  • Study site

    Krakow

  • Study site

    Lublin

  • Study site

    Sopot

  • Study site

    Torun

Other trials in Poland

Ukraine6 sites

  • Study site

    Dnipro

  • Study site

    Donetsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kiev

  • Study site

    Simferopol

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Lithuania5 sites

  • Study site

    Alytus

  • Study site

    Kaunas

  • Study site

    Klaipėda

  • Study site

    Panevezys

  • Study site

    Šiauliai

Other trials in Lithuania

Mexico5 sites

  • Study site

    D. F.

  • Study site

    Mexicalli

  • Study site

    México

  • Study site

    Monterrey

  • Study site

    Tijuana

Other trials in Mexico

Bulgaria3 sites

  • Study site

    Pleven

  • Study site

    Sofia

  • Study site

    Stara Zagora

Other trials in Bulgaria

Russia3 sites

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Yaroslavl

Other trials in Russia

Serbia3 sites

  • Study site

    Belgrade

  • Study site

    Niška Banja

  • Study site

    Novi Sad

Other trials in Serbia

Chile2 sites

  • Study site

    Santiago

  • Study site

    Temuco

Other trials in Chile

Latvia2 sites

  • Study site

    Daugavpils

  • Study site

    Riga

Other trials in Latvia

Slovakia2 sites

  • Study site

    Košice

  • Study site

    Piešťany

Other trials in Slovakia

Croatia1 site

  • Study site

    Rijeka

Other trials in Croatia

Estonia1 site

  • Study site

    Tallinn

Other trials in Estonia

About this study

Official title: A Phase III Multi-center, Double-blind, Placebo-controlled, Parallel Group 24-Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate.

A 24 week study in which patients are given study medication and assessed for signs and symptoms of rheumatoid arthritis. X-rays are performed to assess the progress of joint damage during the study.

Being tested
Certolizumab Pegol
Keywords
Rheumatoid Arthritis, 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 PegolDrug

What is being measured

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

  1. Compare efficacy of two dose regimens of certolizumab pegol in combination with MTX to MTX alone in patients with RA measured by the ACR20 at week 24.

Secondary outcomes (1)

  1. Assess Safety and Tolerability of two dose regimens of certolizumab pegol in combination with MTX and MTX alone in patients with RA; prevention of joint damage in patients with RA; Health Outcomes Measures

Timeline

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

  1. First posted12 Sep 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionSep 2006
  4. Study completionSep 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
590 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00160602
Sponsor's protocol ID
C87050
Other IDs
EudraCT Number: 2005-002326-63
Status last verified
Nov 2020
First submitted
8 Sep 2005
Last updated
1 Dec 2020
Results posted
No

Publications

  • Smolen J, Landewe RB, Mease P, Brzezicki J, Mason D, Luijtens K, van Vollenhoven RF, Kavanaugh A, Schiff M, Burmester GR, Strand V, Vencovsky J, van der Heijde D. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009 Jun;68(6):797-804. doi: 10.1136/ard.2008.101659. Epub 2008 Nov 17.

    PubMed 19015207

  • Strand V, Smolen JS, van Vollenhoven RF, Mease P, Burmester GR, Hiepe F, Khanna D, Nikai E, Coteur G, Schiff M. Certolizumab pegol plus methotrexate provides broad relief from the burden of rheumatoid arthritis: analysis of patient-reported outcomes from the RAPID 2 trial. Ann Rheum Dis. 2011 Jun;70(6):996-1002. doi: 10.1136/ard.2010.143586. Epub 2011 Mar 17.

    PubMed 21415050

  • 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

  • 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

  • Smolen JS, van Vollenhoven R, Kavanaugh A, Strand V, Vencovsky J, Schiff M, Landewe R, Haraoui B, Arendt C, Mountian I, Carter D, van der Heijde D. Certolizumab pegol plus methotrexate 5-year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long-term extension in rheumatoid arthritis patients. Arthritis Res Ther. 2015 Sep 10;17(1):245. doi: 10.1186/s13075-015-0767-2.

    PubMed 26353833

  • 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

  • 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 in people with Rheumatoid Arthritis, run by UCB Pharma at 70 sites in 15 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 8 inclusion and 9 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 70 sites in United States, Czechia, Israel, Poland, Ukraine and 10 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?

Compare efficacy of two dose regimens of certolizumab pegol in combination with MTX to MTX alone in patients with RA measured by the ACR20 at week 24.. 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 NCT00160602, which also lists 8 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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