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
NCT ID: NCT00160641
Last Updated: 2020-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
567 participants
INTERVENTIONAL
2005-11-30
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Certolizumab Pegol
All 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.
Certolizumab Pegol
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.
Interventions
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Certolizumab Pegol
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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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
Countries
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References
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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.
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.
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.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2005-002629-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C87051
Identifier Type: -
Identifier Source: org_study_id
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