Clinical trial NCT00160602: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Certolizumab Pegol, Cimzia
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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after randomization even if they are no longer receiving study treatment in the present study, provided they have not withdrawn their informed consent.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

Primary outcomes:
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.
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Sun City West
country: United States
state: Arizona
city: Palm Desert
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: Naples
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: New Orleans
country: United States
state: Louisiana
city: Saint Louis
country: United States
state: Missouri
city: New Brunswick
country: United States
state: New Jersey
city: Stratford
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Canfield
country: United States
state: Ohio
city: Wynnewood
country: United States
state: Pennsylvania
city: San Antonio
country: United States
state: Texas
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
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.