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
C-early
2 other identifiers
interventional
359
21 countries
170
Brief Summary
This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 \[NCT01519791\]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 rheumatoid-arthritis
Started Jan 2012
Typical duration for phase_3 rheumatoid-arthritis
170 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
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 19, 2012
CompletedFirst Posted
Study publicly available on registry
January 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
January 10, 2017
CompletedJuly 31, 2018
November 1, 2016
3.5 years
January 19, 2012
July 6, 2016
July 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring
This Outcome Measure includes all subjects that have a DAS28 \[ESR\] \<= 3.2 from the start of RA0055 Period 2 (Week 52 of RA0055 Period 1) to Week 104 in RA0055 Period 2 without flaring.
Week 104 in RA0055 Period 2
Secondary Outcomes (37)
Percentage of Subjects With Disease Activity Score 28 [ESR] (DAS28 [ESR]) < 2.6 at Week 52 in Previous Study RA0055 Period 1 Who Maintain a DAS28 [ESR] < 2.6 From Week 52 in RA0055 Period 1 Through Week 104 in RA0055 Period 2 Without Flaring
From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2
From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2
From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2
From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
- +32 more secondary outcomes
Study Arms (3)
CZP 200 mg Q2W + Methotrexate
EXPERIMENTALCZP 200 mg Q4W + Methotrexate
EXPERIMENTALPlacebo + Methotrexate
PLACEBO COMPARATORInterventions
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.
1 syringe of Placebo every 2 Weeks and MTX. The MTX treatment is to remain between 15-25 mg/week.
Eligibility Criteria
You may qualify if:
- \- Those subjects in previous study RA0055 Period 1 who are in sustained LDA (defined as DAS28\[ESR\] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1
You may not qualify if:
- \- Those subjects in previous study RA0055 Period 1 who are NOT in sustained LDA (defined as DAS28\[ESR\] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (178)
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
Related Publications (2)
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.
PMID: 27165179RESULTWeinblatt 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.
PMID: 28666080RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Cares
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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 19, 2012
First Posted
January 31, 2012
Study Start
January 1, 2012
Primary Completion
July 1, 2015
Study Completion
September 1, 2015
Last Updated
July 31, 2018
Results First Posted
January 10, 2017
Record last verified: 2016-11