A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis
NCT ID: NCT01521923
Last Updated: 2018-07-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
359 participants
INTERVENTIONAL
2012-01-31
2015-09-30
Brief Summary
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A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis
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A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis
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A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis
NCT02151851
An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CZP 200 mg Q2W + Methotrexate
Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at dosage strength of 200 mg/ml.
On a maintenance dose of 200 mg every 2 Weeks (Q2W) until Week 102. On a maintenance dose of 200 mg every 4 Weeks (Q4W) until Week 102/ Placebo (PBO) 1 syringe every 4 Weeks (Q4W).
CZP and PBO administration to be staggered 2 Weeks apart to maintain blind.
The MTX treatment is to remain between 15-25 mg/week.
CZP 200 mg Q4W + Methotrexate
Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at dosage strength of 200 mg/ml.
On a maintenance dose of 200 mg every 2 Weeks (Q2W) until Week 102. On a maintenance dose of 200 mg every 4 Weeks (Q4W) until Week 102/ Placebo (PBO) 1 syringe every 4 Weeks (Q4W).
CZP and PBO administration to be staggered 2 Weeks apart to maintain blind.
The MTX treatment is to remain between 15-25 mg/week.
Placebo + Methotrexate
Placebo + Methotrexate (MTX)
1 syringe of Placebo every 2 Weeks and MTX.
The MTX treatment is to remain between 15-25 mg/week.
Interventions
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Certolizumab Pegol + Methotrexate (MTX)
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at dosage strength of 200 mg/ml.
On a maintenance dose of 200 mg every 2 Weeks (Q2W) until Week 102. On a maintenance dose of 200 mg every 4 Weeks (Q4W) until Week 102/ Placebo (PBO) 1 syringe every 4 Weeks (Q4W).
CZP and PBO administration to be staggered 2 Weeks apart to maintain blind.
The MTX treatment is to remain between 15-25 mg/week.
Placebo + Methotrexate (MTX)
1 syringe of Placebo every 2 Weeks and MTX.
The MTX treatment is to remain between 15-25 mg/week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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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209
Birmingham, Alabama, United States
170
Huntsville, Alabama, United States
180
Mobile, Alabama, United States
247
Glendale, Arizona, United States
165
Paradise Valley, Arizona, United States
234
Paradise Valley, Arizona, United States
243
Phoenix, Arizona, United States
251
Tucson, Arizona, United States
160
Covina, California, United States
257
Hemet, California, United States
159
Los Angeles, California, United States
201
San Leandro, California, United States
202
Upland, California, United States
172
Whittier, California, United States
190
Fort Lauderdale, Florida, United States
196
Jupiter, Florida, United States
238
Lake Mary, Florida, United States
232
Miami, Florida, United States
213
Naples, Florida, United States
214
Ocala, Florida, United States
237
Orange Park, Florida, United States
255
Orlando, Florida, United States
163
Palm Harbor, Florida, United States
166
Plantation, Florida, United States
192
Sarasota, Florida, United States
200
Vero Beach, Florida, United States
226
Coeur d'Alene, Idaho, United States
244
Springfield, Illinois, United States
224
South Bend, Indiana, United States
215
Cedar Rapids, Iowa, United States
191
Wichita, Kansas, United States
210
Wichita, Kansas, United States
177
Hagerstown, Maryland, United States
199
Kalamazoo, Michigan, United States
198
Eagan, Minnesota, United States
203
Tupelo, Mississippi, United States
179
St Louis, Missouri, United States
181
Lincoln, Nebraska, United States
256
Reno, Nevada, United States
229
Lebanon, New Hampshire, United States
228
Clifton, New Jersey, United States
207
Albuquerque, New Mexico, United States
176
Brooklyn, New York, United States
242
Plainview, New York, United States
227
Rochester, New York, United States
236
Durham, North Carolina, United States
245
Middleburg Heights, Ohio, United States
241
Oklahoma City, Oklahoma, United States
186
Portland, Oregon, United States
195
Bethlehem, Pennsylvania, United States
167
Duncansville, Pennsylvania, United States
168
Wyomissing, Pennsylvania, United States
189
Charleston, South Carolina, United States
205
Columbia, South Carolina, United States
204
Hendersonville, Tennessee, United States
217
Allen, Texas, United States
185
Amarillo, Texas, United States
161
Austin, Texas, United States
178
Corpus Christi, Texas, United States
162
Dallas, Texas, United States
184
Houston, Texas, United States
206
Houston, Texas, United States
223
Houston, Texas, United States
158
Mesquite, Texas, United States
175
Nassau Bay, Texas, United States
249
Plano, Texas, United States
197
San Antonio, Texas, United States
233
Kennewick, Washington, United States
183
Clarksburg, West Virginia, United States
174
Glendale, Wisconsin, United States
276
Buenos Aires, , Argentina
284
Rosario, , Argentina
279
San Juan, , Argentina
291
San Miguel de Tucumán, , Argentina
6
Coffs Harbour, New South Wales, Australia
2
Herson, Queensland, Australia
1
Maroochydore, Queensland, Australia
8
Woodville South, South Australia, Australia
5
Fitzroy, Victoria, Australia
4
Geelong, Victoria, Australia
3
Malvern, Victoria, Australia
7
Perth, Western Australia, Australia
50
Vienna, , Austria
51
Brussels, , Belgium
126
Gilly, , Belgium
36
Kortrijk, , Belgium
65
Yvoir, , Belgium
240
Kelowna, British Columbia, Canada
235
Hamilton, Ontario, Canada
188
Montreal, Quebec, Canada
194
Trois-Rivières, Quebec, Canada
303
Barranquilla, , Colombia
272
Bogotá, , Colombia
293
Bogotá, , Colombia
299
Bogotá, , Colombia
297
Bucaramanga, , Colombia
288
Chía, , Colombia
271
Medellín, , Colombia
298
Medellín, , Colombia
108
Brno, , Czechia
124
Bruntál, , Czechia
38
Hradec Králové, , Czechia
37
Prague, , Czechia
16
Le Kremlin-Bicêtre, , France
85
Le Mans, , France
88
Montpellier, , France
34
Orléans, , France
79
Strasbourg, , France
52
Bad Doberan, , Germany
17
Bayreuth, , Germany
113
Berlin, , Germany
120
Berlin, , Germany
89
Erfurt, , Germany
70
Frankfurt, , Germany
71
Hamburg, , Germany
81
Hildesheim, , Germany
127
Lingen, , Germany
61
München, , Germany
53
Planegg, , Germany
132
Ratingen, , Germany
49
Rendsburg, , Germany
69
Rheine, , Germany
114
Würzburg, , Germany
59
Zerbst, , Germany
18
Budapest, , Hungary
21
Budapest, , Hungary
86
Eger, , Hungary
131
Szolnok, , Hungary
110
Szombathely, , Hungary
19
Veszprém, , Hungary
33
Cork, , Ireland
54
Dublin, , Ireland
32
Limerick, , Ireland
115
Ferrara, , Italy
122
Milan, , Italy
40
Reggio Emilia, , Italy
72
Roma, , Italy
41
Verona, , Italy
281
Durango, , Mexico
286
Guadalajara, , Mexico
292
Mexico City, , Mexico
302
Mérida, , Mexico
280
Monterrey, , Mexico
294
San Luis Potosí City, , Mexico
78
Monaco, , Monaco
42
Leiden, , Netherlands
128
Bydgoszcz, , Poland
67
Elblag, , Poland
99
Krakow, , Poland
92
Poznan, , Poland
74
Torun, , Poland
100
Warsaw, , Poland
44
Wroclaw, , Poland
58
Brasov, , Romania
111
Bucharest, , Romania
22
Bucharest, , Romania
25
Bucharest, , Romania
26
Bucharest, , Romania
24
Iași, , Romania
57
LASI, , Romania
93
A Coruña, , Spain
47
Madrid, , Spain
63
Santiago de Compostela, , Spain
76
Gothenburg, , Sweden
82
Huddinge, , Sweden
106
Lund, , Sweden
123
Malmo, , Sweden
77
Stockholm, , Sweden
75
Uppsala, , Sweden
118
Fribourg, , Switzerland
68
Sankt Gallen, , Switzerland
125
Cannock, , United Kingdom
105
Dudley, , United Kingdom
56
Leeds, , United Kingdom
121
London, , United Kingdom
27
London, , United Kingdom
80
Sheffield, , United Kingdom
119
York, , United Kingdom
Countries
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References
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Emery P, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, Arendt C, Mountian I, Purcaru O, Tatla D, VanLunen B, Weinblatt ME. Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naive patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study. Ann Rheum Dis. 2017 Jan;76(1):96-104. doi: 10.1136/annrheumdis-2015-209057. Epub 2016 May 10.
Weinblatt ME, Bingham CO 3rd, Burmester GR, Bykerk VP, Furst DE, Mariette X, van der Heijde D, van Vollenhoven R, VanLunen B, Ecoffet C, Cioffi C, Emery P. A Phase III Study Evaluating Continuation, Tapering, and Withdrawal of Certolizumab Pegol After One Year of Therapy in Patients With Early Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Oct;69(10):1937-1948. doi: 10.1002/art.40196. Epub 2017 Sep 12.
Other Identifiers
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2011-001729-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RA0055 Period 2
Identifier Type: -
Identifier Source: org_study_id
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