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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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Certolizumab Pegol
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, Certolizumab Pegol, Cimzia

Eligibility Criteria

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

Inclusion Criteria: 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after randomization even if they are no longer receiving study treatment in the present study, provided they have not withdrawn their informed consent. Exclusion Criteria: 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. 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).

Sites / Locations

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
September 8, 2005
Last Updated
November 26, 2020
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00160602
Brief Title
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
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.
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
UCB Pharma

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Certolizumab Pegol
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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).
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
Montgomery
State/Province
Alabama
Country
United States
City
Sun City West
State/Province
Arizona
Country
United States
City
Palm Desert
State/Province
California
Country
United States
City
Pasadena
State/Province
California
Country
United States
City
Santa Maria
State/Province
California
Country
United States
City
Naples
State/Province
Florida
Country
United States
City
Palm Harbor
State/Province
Florida
Country
United States
City
South Miami
State/Province
Florida
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
New Brunswick
State/Province
New Jersey
Country
United States
City
Stratford
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Canfield
State/Province
Ohio
Country
United States
City
Wynnewood
State/Province
Pennsylvania
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Pleven
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Stara Zagora
Country
Bulgaria
City
Santiago
Country
Chile
City
Temuco
Country
Chile
City
Rijeka
Country
Croatia
City
Brno
Country
Czechia
City
Hlucin
Country
Czechia
City
Ostrava-Poruba
Country
Czechia
City
Praha 2
Country
Czechia
City
Praha 5
Country
Czechia
City
Sokolov
Country
Czechia
City
UherskeHradiste
Country
Czechia
City
Zlin
Country
Czechia
City
Tallinn
Country
Estonia
City
Afula
Country
Israel
City
Ashkelon
Country
Israel
City
Beer Yaakov
Country
Israel
City
Haifa
Country
Israel
City
Jerusalem
Country
Israel
City
Ramat Gan
Country
Israel
City
Rehovot
Country
Israel
City
Daugavpils
Country
Latvia
City
Riga
Country
Latvia
City
Alytus
Country
Lithuania
City
Kaunas
Country
Lithuania
City
Klaipeda
Country
Lithuania
City
Panevezys
Country
Lithuania
City
Siauliai
Country
Lithuania
City
D. F.
Country
Mexico
City
Mexicalli
Country
Mexico
City
Mexico
Country
Mexico
City
Monterrey
Country
Mexico
City
Tijuana
Country
Mexico
City
Bialystok
Country
Poland
City
Elblag
Country
Poland
City
Krakow
Country
Poland
City
Lublin
Country
Poland
City
Sopot
Country
Poland
City
Torun
Country
Poland
City
Moscow
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
City
Belgrade
Country
Serbia
City
Niska Banja
Country
Serbia
City
Novi Sad
Country
Serbia
City
Kosice
Country
Slovakia
City
Piestany
Country
Slovakia
City
Dnepropetrovsk
Country
Ukraine
City
Donetsk
Country
Ukraine
City
Ivano-Frankivsk
Country
Ukraine
City
Kiev
Country
Ukraine
City
Simferopol
Country
Ukraine
City
Zaporozhye
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
19015207
Citation
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.
Results Reference
result
PubMed Identifier
21415050
Citation
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.
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
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
26353833
Citation
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.
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
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 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

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