A Study of the Safety and Effectiveness of Liquid 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-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050
2 other identifiers
interventional
567
13 countries
67
Brief Summary
An open ended study in which patients who completed the preceding double-blind study NCT00160602 are given Certolizumab Pegol and assessed for signs and symptoms of Rheumatoid Arthritis.
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 Nov 2005
Longer than P75 for phase_3 rheumatoid-arthritis
67 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
First Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedStudy Start
First participant enrolled
November 1, 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 7, 2013
CompletedMarch 27, 2020
March 1, 2020
6.3 years
September 8, 2005
January 31, 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 6.8 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 CZP was at Baseline of the preceding double-blind study NCT00160602 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 6.8 years)
Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 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 NCT00160602 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 6.8 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 6.3 years)
Secondary Outcomes (25)
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52
From Baseline of the preceding double-blind study to Week 52 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100
From Baseline of the preceding double-blind study to Week 100 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148
From Baseline of the preceding double-blind study to Week 148 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196
From Baseline of the preceding double-blind study to Week 196 of the open-label study
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244
From Baseline of the preceding double-blind study to Week 244 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: 1 ml of Liquid product 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 an American College of Rheumatology 20 % (ACR20) response at Weeks 12 and 14 in C87050 \[NCT00160602\], or must have completed the entire Week 24 assessment of C87050 \[NCT00160602\] 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 (RA)
- Any concomitant biological therapy
- Any experimental therapy, within or outside a clinical
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (67)
172
Palm Desert, California, United States
185
Pasadena, California, United States
170
Santa Maria, California, United States
194
Whittier, California, United States
176
Naples, Florida, United States
186
Palm Harbor, Florida, United States
188
Kansas City, Missouri, United States
182
St Louis, Missouri, United States
178
Stratford, New Jersey, United States
192
Amarillo, Texas, United States
173
Austin, Texas, United States
175
San Antonio, Texas, United States
303
Pleven, Bulgaria
302
Sofia, Bulgaria
500
Rijeka, Croatia
600
Brno, Czechia
603
Hlučín, Czechia
605
Prague, Czechia
606
Prague, Czechia
604
Sokolov, Czechia
602
Uherské Hradiště, Czechia
607
Zlín, Czechia
700
Tallinn, Estonia
802
Afula, Israel
805
Ashkelon, Israel
807
Haifa, Israel
804
Jerusalem, Israel
801
Ramat Gan, Israel
806
Ẕerifin, Israel
901
Daugavpils, Latvia
900
Riga, Latvia
103
Alytus, Lithuania
100
Kaunas, Lithuania
102
Klaipėda, Lithuania
101
Šiauliai, Lithuania
124
Bialystok, Poland
120
Elblag, Poland
123
Krakow, Poland
125
Lublin, Poland
121
Sopot, Poland
122
Torun, Poland
150
Moscow, Russia
151
Moscow, Russia
156
Moscow, Russia
159
Moscow, Russia
152
Saint Petersburg, Russia
154
Saint Petersburg, Russia
155
Saint Petersburg, Russia
158
Saint Petersburg, Russia
153
Yaroslavl, Russia
132
Belgrade, Serbia
133
Belgrade, Serbia
131
Niška Banja, Serbia
141
Košice, Slovakia
143
Košice, Slovakia
140
Piešťany, Slovakia
142
Piešťany, Slovakia
162
Dnipro, Ukraine
161
Donetsk, Ukraine
168
Donetsk, Ukraine
165
Ivano-Frankivsk, Ukraine
163
Kiev, Ukraine
164
Kiev, Ukraine
167
Kiev, Ukraine
169
Kiev, Ukraine
160
Simferopol, Ukraine
166
Zaporizhzhya, Ukraine
Related Publications (3)
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: 32100960BACKGROUNDCurtis 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 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.
PMID: 26353833DERIVED
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 8, 2005
First Posted
September 12, 2005
Study Start
November 1, 2005
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
March 27, 2020
Results First Posted
March 7, 2013
Record last verified: 2020-03