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
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
2 other identifiers
interventional
857
22 countries
121
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Jun 2005
Longer than P75 for phase_3 rheumatoid-arthritis
121 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
March 8, 2013
CompletedMarch 26, 2020
March 1, 2020
6.7 years
September 9, 2005
February 4, 2013
March 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study \[NCT00152386\] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.
From first dose of CZP to the end of the open-label study (approximately 7 years)
Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
A SAE is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly or birth defect * Is as infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above First dose of CZP was at Baseline of the preceding double-blind study \[NCT00152386\] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.
From first dose of CZP to the end of the open-label study (approximately 7 years)
Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.
From Entry Visit (Week 0) to the end of the study (approximately 6.5 years)
Secondary Outcomes (25)
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48
From Baseline of the preceding double-blind study to Week 48 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96
From Baseline of the preceding double-blind study to Week 96 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144
From Baseline of the preceding double-blind study to Week 144 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192
From Baseline of the preceding double-blind study to Week 192 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240
From Baseline of the preceding double-blind study to Week 240 of the open-label study
- +20 more secondary outcomes
Study Arms (1)
Certolizumab Pegol
EXPERIMENTALAll patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Interventions
Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (121)
152
Huntsville, Alabama, United States
148
San Diego, California, United States
153
Danbury, Connecticut, United States
133
Ocala, Florida, United States
140
Orlando, Florida, United States
150
Orlando, Florida, United States
145
Sarasota, Florida, United States
136
Tampa, Florida, United States
157
Coeur d'Alene, Idaho, United States
155
Springfield, Illinois, United States
134
Wheaton, Maryland, United States
151
St Louis, Missouri, United States
156
Lincoln, Nebraska, United States
135
Charlotte, North Carolina, United States
147
Cleveland, Ohio, United States
158
Dayton, Ohio, United States
139
Charleston, South Carolina, United States
137
Austin, Texas, United States
143
San Antonio, Texas, United States
12
Buenos Aires, Argentina
14
Capital Federal, Argentina
1
Capital Federal, Argentina
9
Capital Federal, Argentina
8
Ciudad Autonoma de Buenos Aire, Argentina
11
Córdoba, Argentina
2
Córdoba, Argentina
13
Quilmes, Argentina
7
Rosario, Argentina
10
San Miguel de Tucumán, Argentina
6
Santa Fe, Argentina
18
Malvern, Australia
21
Maroochydore, Australia
23
Perth, Australia
179
Antwerp, Belgium
199
Liège, Belgium
177
Merksem, Belgium
29
Pleven, Bulgaria
221
Sofia, Bulgaria
28
Sofia, Bulgaria
30
Sofia, Bulgaria
26
Stara Zagora, Bulgaria
43
Newmarket, Ontario, Canada
32
Toronto, Ontario, Canada
39
Toronto, Ontario, Canada
35
Hamilton, Canada
36
Kitchener, Canada
201
Pointe-Claire, Canada
31
Sainte-Foy, Canada
203
Winnipeg, Canada
190
Santiago, Chile
49
Santiago, Chile
44
Valdivia, Chile
52
Rijeka, Croatia
56
Brno, Czechia
57
Ostrava Trebovice, Czechia
187
Pilsen, Czechia
55
Prague, Czechia
60
Prague, Czechia
61
Prague, Czechia
58
Uherské Hradiště, Czechia
62
Zlín, Czechia
64
Pärnu, Estonia
65
Tallinn, Estonia
63
Tartu, Estonia
68
Hyvinkää, Finland
160
Montpellier, France
71
Budapest, Hungary
73
Budapest, Hungary
75
Bupadest, Hungary
191
Debrecen, Hungary
76
Miskolc, Hungary
74
Szolnok, Hungary
79
Afula, Israel
82
Ashkelon, Israel
81
Haifa, Israel
83
Haifa, Israel
78
Ramat Gan, Israel
77
Tel Aviv, Israel
85
Ẕerifin, Israel
86
Riga, Latvia
88
Riga, Latvia
92
Alytus, Lithuania
89
Kaunas, Lithuania
91
Klaipėda, Lithuania
93
Panevezys, Lithuania
90
Šiauliai, Lithuania
94
Vilnius, Lithuania
95
Mexicalli, Mexico
96
Monterrey, Mexico
103
Auckland, New Zealand
101
Christchurch, New Zealand
100
South Canterbury, New Zealand
192
Tauranga, New Zealand
107
Moscow, Russia
113
Moscow, Russia
222
Moscow, Russia
223
Moscow, Russia
224
Moscow, Russia
109
Saint Petersburg, Russia
111
Saint Petersburg, Russia
112
Saint Petersburg, Russia
193
Saint Petersburg, Russia
110
Yaroslavl, Russia
117
Belgrade, Serbia
118
Belgrade, Serbia
114
Niška Banja, Serbia
115
Novi Sad, Serbia
119
Bratislava, Slovakia
121
Košice, Slovakia
120
Piešťany, Slovakia
122
Piešťany, Slovakia
210
Dnipro, Ukraine
209
Donetsk, Ukraine
216
Donetsk, Ukraine
213
Ivano-Frankivsk, Ukraine
211
Kiev, Ukraine
212
Kiev, Ukraine
215
Kiev, Ukraine
220
Kiev, Ukraine
208
Symferopyl, Ukraine
214
Zaporizhzhya, Ukraine
Related Publications (6)
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.
PMID: 32100960BACKGROUNDKeystone 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.
PMID: 22596211RESULTvan 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.
PMID: 22589265RESULTCurtis 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.
PMID: 21484766RESULTCurtis 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.
PMID: 29246162DERIVEDSmolen 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.
PMID: 19015207DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
June 1, 2005
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
March 26, 2020
Results First Posted
March 8, 2013
Record last verified: 2020-03