Clinical trial NCT00175877: A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol 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-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
CDP870
Certolizumab Pegol
Cimzia
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 857
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open ended study in which patients who completed the double-blind study CDP870-027 \[NCT00152386\] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).


Eligibility criteria: Inclusion Criteria:

Patients must have either failed to achieve American College of Rheumatology 20 % Response Criteria (ACR20) at Weeks 12 and 14 in C87027 \[NCT00152386\], or must have completed the entire Week 52 assessment of C87027 \[NCT00152386\] trial.

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. Osteoarthritis 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 Rheumatoid Arthritis
* Any concomitant biological therapy
* Any experimental therapy, within or outside a clinical trial

Primary outcomes:
measure: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
timeFrame: From first dose of CZP to the end of the open-label study (approximately 7 years)
measure: Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
timeFrame: From first dose of CZP to the end of the open-label study (approximately 7 years)
measure: Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study
timeFrame: From Entry Visit (Week 0) to the end of the study (approximately 6.5 years)
Secondary outcomes:
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48
timeFrame: From Baseline of the preceding double-blind study to Week 48 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96
timeFrame: From Baseline of the preceding double-blind study to Week 96 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144
timeFrame: From Baseline of the preceding double-blind study to Week 144 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192
timeFrame: From Baseline of the preceding double-blind study to Week 192 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240
timeFrame: From Baseline of the preceding double-blind study to Week 240 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48
timeFrame: From Baseline of the preceding double-blind study to Week 48 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96
timeFrame: From Baseline of the preceding double-blind study to Week 96 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144
timeFrame: From Baseline of the preceding double-blind study to Week 144 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192
timeFrame: From Baseline of the preceding double-blind study to Week 192 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240
timeFrame: From Baseline of the preceding double-blind study to Week 240 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48
timeFrame: From Baseline of the preceding double-blind study to Week 48 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96
timeFrame: From Baseline of the preceding double-blind study to Week 96 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144
timeFrame: From Baseline of the preceding double-blind study to Week 144 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192
timeFrame: From Baseline of the preceding double-blind study to Week 192 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240
timeFrame: From Baseline of the preceding double-blind study to Week 240 of the open-label study
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
measure: Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS)
timeFrame: From Baseline of the preceding double-blind study to Week 96 of the open-label study
measure: Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
measure: Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
measure: Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
measure: Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
measure: Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
measure: Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score
timeFrame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: 152
state: Alabama
city: San Diego
country: United States
facility: 148
state: California
city: Danbury
country: United States
facility: 153
state: Connecticut
city: Ocala
country: United States
facility: 133
state: Florida
city: Orlando
country: United States
facility: 140
state: Florida
city: Orlando
country: United States
facility: 150
state: Florida
city: Sarasota
country: United States
facility: 145
state: Florida
city: Tampa
country: United States
facility: 136
state: Florida
city: Coeur d'Alene
country: United States
facility: 157
state: Idaho
city: Springfield
country: United States
facility: 155
state: Illinois
city: Wheaton
country: United States
facility: 134
state: Maryland
city: Saint Louis
country: United States
facility: 151
state: Missouri
city: Lincoln
country: United States
facility: 156
state: Nebraska
city: Charlotte
country: United States
facility: 135
state: North Carolina
city: Cleveland
country: United States
facility: 147
state: Ohio
city: Dayton
country: United States
facility: 158
state: Ohio
city: Charleston
country: United States
facility: 139
state: South Carolina
city: Austin
country: United States
facility: 137
state: Texas
city: San Antonio
country: United States
facility: 143
state: Texas
city: Buenos Aires
country: Argentina
facility: 12
city: Capital Federal
country: Argentina
facility: 14
city: Capital Federal
country: Argentina
facility: 1
city: Capital Federal
country: Argentina
facility: 9
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: 8
city: Cordoba
country: Argentina
facility: 11
city: Cordoba
country: Argentina
facility: 2
city: Quilmes
country: Argentina
facility: 13
city: Rosario
country: Argentina
facility: 7
city: San Miguel de Tucuman
country: Argentina
facility: 10
city: Santa Fe
country: Argentina
facility: 6
city: Malvern
country: Australia
facility: 18
city: Maroochydore
country: Australia
facility: 21
city: Perth
country: Australia
facility: 23
city: Antwerpen
country: Belgium
facility: 179
city: Liege
country: Belgium
facility: 199
city: Merksem
country: Belgium
facility: 177
city: Pleven
country: Bulgaria
facility: 29
city: Sofia
country: Bulgaria
facility: 221
city: Sofia
country: Bulgaria
facility: 28
city: Sofia
country: Bulgaria
facility: 30
city: Stara Zagora
country: Bulgaria
facility: 26
city: Newmarket
country: Canada
facility: 43
state: Ontario
city: Toronto
country: Canada
facility: 32
state: Ontario
city: Toronto
country: Canada
facility: 39
state: Ontario
city: Hamilton
country: Canada
facility: 35
city: Kitchener
country: Canada
facility: 36
city: Pointe Claire
country: Canada
facility: 201
city: Sainte Foy
country: Canada
facility: 31
city: Winnipeg
country: Canada
facility: 203
city: Santiago de Chile
country: Chile
facility: 190
city: Santiago de Chile
country: Chile
facility: 49
city: Valdivia
country: Chile
facility: 44
city: Rijeka
country: Croatia
facility: 52
city: Brno
country: Czechia
facility: 56
city: Ostrava Trebovice
country: Czechia
facility: 57
city: Plzen
country: Czechia
facility: 187
city: Praha 2
country: Czechia
facility: 61
city: Praha 5
country: Czechia
facility: 60
city: Praha
country: Czechia
facility: 55
city: Uherske Hradiste
country: Czechia
facility: 58
city: Zlin
country: Czechia
facility: 62
city: Parnu
country: Estonia
facility: 64
city: Tallinn
country: Estonia
facility: 65
city: Tartu
country: Estonia
facility: 63
city: Hyvinkaa
country: Finland
facility: 68
city: Montpellier Cedex 5
country: France
facility: 160
city: Budapest
country: Hungary
facility: 71
city: Budapest
country: Hungary
facility: 73
city: Bupadest
country: Hungary
facility: 75
city: Debrecen
country: Hungary
facility: 191
city: Miskolc
country: Hungary
facility: 76
city: Szolnok
country: Hungary
facility: 74
city: Afula
country: Israel
facility: 79
city: Ashkelon
country: Israel
facility: 82
city: Haifa
country: Israel
facility: 81
city: Haifa
country: Israel
facility: 83
city: Ramat Gan
country: Israel
facility: 78
city: Tel Aviv
country: Israel
facility: 77
city: Zerifin
country: Israel
facility: 85
city: Riga
country: Latvia
facility: 86
city: Riga
country: Latvia
facility: 88
city: Alytus
country: Lithuania
facility: 92
city: Kaunas
country: Lithuania
facility: 89
city: Klaipeda
country: Lithuania
facility: 91
city: Panevezys
country: Lithuania
facility: 93
city: Siauliai
country: Lithuania
facility: 90
city: Vilnius
country: Lithuania
facility: 94
city: Mexicalli
country: Mexico
facility: 95
city: Monterrey
country: Mexico
facility: 96
city: Auckland
country: New Zealand
facility: 103
city: Christchurch
country: New Zealand
facility: 101
city: South Canterbury
country: New Zealand
facility: 100
city: Tauranga
country: New Zealand
facility: 192
city: Moscow
country: Russian Federation
facility: 107
city: Moscow
country: Russian Federation
facility: 113
city: Moscow
country: Russian Federation
facility: 222
city: Moscow
country: Russian Federation
facility: 223
city: Moscow
country: Russian Federation
facility: 224
city: St. Petersburg
country: Russian Federation
facility: 109
city: St. Petersburg
country: Russian Federation
facility: 111
city: St. Petersburg
country: Russian Federation
facility: 112
city: St. Petersburg
country: Russian Federation
facility: 193
city: Yaroslavl
country: Russian Federation
facility: 110
city: Belgrade
country: Serbia
facility: 117
city: Belgrade
country: Serbia
facility: 118
city: Niska Banja
country: Serbia
facility: 114
city: Novi Sad
country: Serbia
facility: 115
city: Bratislava
country: Slovakia
facility: 119
city: Kosice
country: Slovakia
facility: 121
city: Piestany
country: Slovakia
facility: 120
city: Piestany
country: Slovakia
facility: 122
city: Dnepropetrovsk
country: Ukraine
facility: 210
city: Donetsk
country: Ukraine
facility: 209
city: Donetsk
country: Ukraine
facility: 216
city: Ivano-Frankivsk
country: Ukraine
facility: 213
city: Kiev
country: Ukraine
facility: 211
city: Kiev
country: Ukraine
facility: 212
city: Kiev
country: Ukraine
facility: 215
city: Kiev
country: Ukraine
facility: 220
city: Symferopyl
country: Ukraine
facility: 208
city: Zaporozhye
country: Ukraine
facility: 214
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
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: Keystone EC, Combe B, Smolen J, Strand V, Goel N, van Vollenhoven R, Mease P, Landewe R, Fleischmann R, Luijtens K, van der Heijde D. Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial. Rheumatology (Oxford). 2012 Sep;51(9):1628-38. doi: 10.1093/rheumatology/kes082. Epub 2012 May 16.
citation: 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.
citation: 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.
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 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.