Clinical trial NCT01521923: 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
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Certolizumab Pegol - Cimzia
Rheumatoid Arthritis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-01-31
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Primary outcomes:
measure: Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring
timeFrame: Week 104 in RA0055 Period 2
Secondary outcomes:
measure: 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
timeFrame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2
timeFrame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2
timeFrame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2
timeFrame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2
timeFrame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Change From Baseline in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2
timeFrame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2
timeFrame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Change From Baseline in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2
timeFrame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2
timeFrame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 104 in RA0055 Period 2
timeFrame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 104 in RA0055 Period 2
timeFrame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 104 in RA0055 Period 2
timeFrame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Percentage of Subjects With Clinical Disease Activity Index (CDAI) <= 2.8 at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Percentage of Subjects With Simplified Disease Activity Index (SDAI) <= 3.3 at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 104 in RA0055 Period 2
timeFrame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Change From Baseline in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2
timeFrame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Change From Week 52 in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2
timeFrame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Change From Baseline in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2
timeFrame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Change From Week 52 in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2
timeFrame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Change From Baseline in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2
timeFrame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Change From Week 52 in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2
timeFrame: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Time to Flare From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Change From Baseline in Previous Study RA0055 Period 1 in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 104 in RA0055 Period 2
timeFrame: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
measure: Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
measure: Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 104 in RA0055 Period 2
timeFrame: Week 104 in RA0055 Period 2
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 209
state: Alabama
city: Huntsville
country: United States
facility: 170
state: Alabama
city: Mobile
country: United States
facility: 180
state: Alabama
city: Glendale
country: United States
facility: 247
state: Arizona
city: Paradise Valley
country: United States
facility: 165
state: Arizona
city: Paradise Valley
country: United States
facility: 234
state: Arizona
city: Phoenix
country: United States
facility: 243
state: Arizona
city: Tucson
country: United States
facility: 251
state: Arizona
city: Covina
country: United States
facility: 160
state: California
city: Hemet
country: United States
facility: 257
state: California
city: Los Angeles
country: United States
facility: 159
state: California
city: San Leandro
country: United States
facility: 201
state: California
city: Upland
country: United States
facility: 202
state: California
city: Whittier
country: United States
facility: 172
state: California
city: Fort Lauderdale
country: United States
facility: 190
state: Florida
city: Jupiter
country: United States
facility: 196
state: Florida
city: Lake Mary
country: United States
facility: 238
state: Florida
city: Miami
country: United States
facility: 232
state: Florida
city: Naples
country: United States
facility: 213
state: Florida
city: Ocala
country: United States
facility: 214
state: Florida
city: Orange Park
country: United States
facility: 237
state: Florida
city: Orlando
country: United States
facility: 255
state: Florida
city: Palm Harbor
country: United States
facility: 163
state: Florida
city: Plantation
country: United States
facility: 166
state: Florida
city: Sarasota
country: United States
facility: 192
state: Florida
city: Vero Beach
country: United States
facility: 200
state: Florida
city: Coeur d'Alene
country: United States
facility: 226
state: Idaho
city: Springfield
country: United States
facility: 244
state: Illinois
city: South Bend
country: United States
facility: 224
state: Indiana
city: Cedar Rapids
country: United States
facility: 215
state: Iowa
city: Wichita
country: United States
facility: 191
state: Kansas
city: Wichita
country: United States
facility: 210
state: Kansas
city: Hagerstown
country: United States
facility: 177
state: Maryland
city: Kalamazoo
country: United States
facility: 199
state: Michigan
city: Eagan
country: United States
facility: 198
state: Minnesota
city: Tupelo
country: United States
facility: 203
state: Mississippi
city: Saint Louis
country: United States
facility: 179
state: Missouri
city: Lincoln
country: United States
facility: 181
state: Nebraska
city: Reno
country: United States
facility: 256
state: Nevada
city: Lebanon
country: United States
facility: 229
state: New Hampshire
city: Clifton
country: United States
facility: 228
state: New Jersey
city: Albuquerque
country: United States
facility: 207
state: New Mexico
city: Brooklyn
country: United States
facility: 176
state: New York
city: Plainview
country: United States
facility: 242
state: New York
city: Rochester
country: United States
facility: 227
state: New York
city: Durham
country: United States
facility: 236
state: North Carolina
city: Middleburg Heights
country: United States
facility: 245
state: Ohio
city: Oklahoma City
country: United States
facility: 241
state: Oklahoma
city: Portland
country: United States
facility: 186
state: Oregon
city: Bethlehem
country: United States
facility: 195
state: Pennsylvania
city: Duncansville
country: United States
facility: 167
state: Pennsylvania
city: Wyomissing
country: United States
facility: 168
state: Pennsylvania
city: Charleston
country: United States
facility: 189
state: South Carolina
city: Columbia
country: United States
facility: 205
state: South Carolina
city: Hendersonville
country: United States
facility: 204
state: Tennessee
city: Allen
country: United States
facility: 217
state: Texas
city: Amarillo
country: United States
facility: 185
state: Texas
city: Austin
country: United States
facility: 161
state: Texas
city: Corpus Christi
country: United States
facility: 178
state: Texas
city: Dallas
country: United States
facility: 162
state: Texas
city: Houston
country: United States
facility: 184
state: Texas
city: Houston
country: United States
facility: 206
state: Texas
city: Houston
country: United States
facility: 223
state: Texas
city: Mesquite
country: United States
facility: 158
state: Texas
city: Nassau Bay
country: United States
facility: 175
state: Texas
city: Plano
country: United States
facility: 249
state: Texas
city: San Antonio
country: United States
facility: 197
state: Texas
city: Kennewick
country: United States
facility: 233
state: Washington
city: Clarksburg
country: United States
facility: 183
state: West Virginia
city: Glendale
country: United States
facility: 174
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: 276
city: Rosario
country: Argentina
facility: 284
city: San Juan
country: Argentina
facility: 279
city: Tucuman
country: Argentina
facility: 291
city: Coffs Harbour
country: Australia
facility: 6
state: New South Wales
city: Herson
country: Australia
facility: 2
state: Queensland
city: Maroochydore
country: Australia
facility: 1
state: Queensland
city: Woodville South
country: Australia
facility: 8
state: South Australia
city: Fitzroy
country: Australia
facility: 5
state: Victoria
city: Geelong
country: Australia
facility: 4
state: Victoria
city: Malvern
country: Australia
facility: 3
state: Victoria
city: Perth
country: Australia
facility: 7
state: Western Australia
city: Wien
country: Austria
facility: 50
city: Brussels
country: Belgium
facility: 51
city: Gilly
country: Belgium
facility: 126
city: Kortrijk
country: Belgium
facility: 36
city: Yvoir
country: Belgium
facility: 65
city: Kelowna
country: Canada
facility: 240
state: British Columbia
city: Hamilton
country: Canada
facility: 235
state: Ontario
city: Montreal
country: Canada
facility: 188
state: Quebec
city: Trois-rivieres
country: Canada
facility: 194
state: Quebec
city: Barranquilla
country: Colombia
facility: 303
city: Bogota
country: Colombia
facility: 272
city: Bogota
country: Colombia
facility: 293
city: Bogota
country: Colombia
facility: 299
city: Bucaramanga
country: Colombia
facility: 297
city: Chia
country: Colombia
facility: 288
city: Medellin
country: Colombia
facility: 271
city: Medellin
country: Colombia
facility: 298
city: Brno
country: Czechia
facility: 108
city: Bruntal
country: Czechia
facility: 124
city: Hradec Kralove
country: Czechia
facility: 38
city: Praha
country: Czechia
facility: 37
city: Le Kremlin Bicetre
country: France
facility: 16
city: Le Mans
country: France
facility: 85
city: Montpellier Cedex 5
country: France
facility: 88
city: Orleans
country: France
facility: 34
city: Strasbourg
country: France
facility: 79
city: Bad Doberan
country: Germany
facility: 52
city: Bayreuth
country: Germany
facility: 17
city: Berlin
country: Germany
facility: 113
city: Berlin
country: Germany
facility: 120
city: Erfurt
country: Germany
facility: 89
city: Frankfurt
country: Germany
facility: 70
city: Hamburg
country: Germany
facility: 71
city: Hildesheim
country: Germany
facility: 81
city: Lingen
country: Germany
facility: 127
city: München
country: Germany
facility: 61
city: Planegg
country: Germany
facility: 53
city: Ratingen
country: Germany
facility: 132
city: Rendsburg
country: Germany
facility: 49
city: Rheine
country: Germany
facility: 69
city: Würzburg
country: Germany
facility: 114
city: Zerbst
country: Germany
facility: 59
city: Budapest
country: Hungary
facility: 18
city: Budapest
country: Hungary
facility: 21
city: Eger
country: Hungary
facility: 86
city: Szolnok
country: Hungary
facility: 131
city: Szombathely
country: Hungary
facility: 110
city: Veszprem
country: Hungary
facility: 19
city: Cork
country: Ireland
facility: 33
city: Dublin
country: Ireland
facility: 54
city: Limerick
country: Ireland
facility: 32
city: Ferrara
country: Italy
facility: 115
city: Milano
country: Italy
facility: 122
city: Reggio Emilia
country: Italy
facility: 40
city: Roma
country: Italy
facility: 72
city: Verona
country: Italy
facility: 41
city: Durango
country: Mexico
facility: 281
city: Guadalajara
country: Mexico
facility: 286
city: Merida
country: Mexico
facility: 302
city: Mexico D.F.
country: Mexico
facility: 292
city: Monterrey
country: Mexico
facility: 280
city: San Luis Potosi
country: Mexico
facility: 294
city: Monaco
country: Monaco
facility: 78
city: Leiden
country: Netherlands
facility: 42
city: Bydgoszcz
country: Poland
facility: 128
city: Elblag
country: Poland
facility: 67
city: Krakow
country: Poland
facility: 99
city: Poznan
country: Poland
facility: 92
city: Torun
country: Poland
facility: 74
city: Warszawa
country: Poland
facility: 100
city: Wroclaw
country: Poland
facility: 44
city: Brasov
country: Romania
facility: 58
city: Bucharest
country: Romania
facility: 111
city: Bucharest
country: Romania
facility: 22
city: Bucharest
country: Romania
facility: 25
city: Bucharest
country: Romania
facility: 26
city: Iasi
country: Romania
facility: 24
city: Lasi
country: Romania
facility: 57
city: Coruna
country: Spain
facility: 93
city: Madrid
country: Spain
facility: 47
city: Santiago de Compostela
country: Spain
facility: 63
city: Göteborg
country: Sweden
facility: 76
city: Huddinge
country: Sweden
facility: 82
city: Lund
country: Sweden
facility: 106
city: Malmö
country: Sweden
facility: 123
city: Stockholm
country: Sweden
facility: 77
city: Uppsala
country: Sweden
facility: 75
city: Fribourg
country: Switzerland
facility: 118
city: St. Gallen
country: Switzerland
facility: 68
city: Cannock
country: United Kingdom
facility: 125
city: Dudley
country: United Kingdom
facility: 105
city: Leeds
country: United Kingdom
facility: 56
city: London
country: United Kingdom
facility: 121
city: London
country: United Kingdom
facility: 27
city: Sheffield
country: United Kingdom
facility: 80
city: York
country: United Kingdom
facility: 119
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.