Clinical trial NCT01255761: A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects
Official title: Phase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving Cimzia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Certolizumab Pegol
Cimzia
Rheumatoid Arthritis
CDAI
RAPID3
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-12-07
Enrollment: 736
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: Phase 4 study to evaluate a routine patient completed assessment (RAPID3) compared to a physician completed assessment (CDAI) to predict treatment success with subjects with moderate to severe rheumatoid arthritis

Detailed description: RA0064 is a Phase 4, multicenter, randomized, 52-week study. All eligible subjects will receive open label Cimzia 400 mg at Weeks 0, 2 and 4, followed by Cimzia 200 mg every 2 weeks at Weeks 6 to 50 for the treatment of moderate to severe rheumatoid arthritis. All subjects will be assessed using the 2 assessment tools: the subject-based Routine Assessment of Patient Index (RAPID3) and the investigator-based Clinical Disease Activity Index (CDAI)

Eligibility criteria: Inclusion Criteria:

* Subjects 18 years of age or older
* Subjects with a diagnosis of Adult-onset Rheumatoid Arthritis of at least 3 months as defined by the 1987 American College of Rheumatology (ACR) classification criteria
* Subjects with active Rheumatoid Arthritis as defined by:

  * 4 tender joints (28 joint count) at Screening and Baseline Visits; and
  * 4 swollen joints (28 joint count) at Screening and Baseline Visits
* Subjects who have had an unsatisfactory response or intolerance to at least 1 traditional Disease-modifying Antirheumatic Drugs (DMARD)

Exclusion Criteria:

* Subjects must not have a diagnosis of any other inflammatory Arthritis
* Subjects must not have greater than 3 Arthroplasties due to Rheumatoid Arthritis and/or Steinbrocker IV Functional Capacity
* Subjects must not have a secondary non-inflammatory type of Arthritis that would interfere with study evaluation
* Subjects must not be diagnosed with Fibromyalgia with sufficient symptoms requiring treatment
* Subjects must not have a history of Infected Joint Prosthesis
* Subjects must not have discontinued biological therapy for their Rheumatoid Arthritis due to Severe Hypersensitivity Reaction or Anaphylactic Reaction
* Subjects must not have received more than 2 anti- Tumor Necrosis Factor (TNF) agents prior to enrollment
* Subjects must not have received treatment with Abatacept and/or Rituximab or have received any experimental or approved B cell therapeutic agent
* Subjects must not have a history of chronic alcohol or drug abuse
* Subjects must not have known hypersensitivity to any components of the investigational medicinal product
* Subjects must not have a history of chronic infections, recent serious or life-threatening infection within 6 months or any current sign or symptom that may indicate an infection
* Subjects must not have a history of a Blood Dyscrasias
* Subjects with known Tuberculosis (TB) Disease, high risk of acquiring TB or latent TB infection
* Subjects must not be at high risk of infection
* Subjects must not have a history of Lymphoproliferative Disorder including Lymphoma signs and symptoms suggestive of Lymphoproliferative Disease
* Subjects must not have concurrent acute or chronic Viral Hepatitis B or C
* Subjects must not have known Human Immunodeficiency Virus (HIV) infection
* Subject must not have concurrent Malignancy or history of Malignancy
* Subjects must not have a current or recent history of severe, progressive, and/or uncontrolled Renal, Hepatic, Hematological, Gastrointestinal, Endocrine, Pulmonary, Cardiac, Neurological or Cerebral Disease
* Subjects must not have Class III or IV Congestive Heart Failure
* Subjects must not have history of, or suspected Demyelinating Disease of the Central Nervous System
* Subjects must not have a history of adverse reaction to Polyethylene Glycol (PEG)
* Subjects must not have significant laboratory abnormalities which in the investigators judgment would make the subject unsuitable for inclusion
* Subjects must not have a known history or clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, Nontuberculous Mycobacteria, Blastomyces or Aspergillus
* Subject must not have a known history of or be currently diagnosed with Systemic Lupus Erythematosus

Primary outcomes:
measure: Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]
timeFrame: Baseline (Week 0) to Week 12
measure: Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52
timeFrame: Baseline (Week 0) to Week 52
Secondary outcomes:
measure: Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52
timeFrame: Baseline (Week 0) to Week 52
measure: Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52
timeFrame: Baseline (Week 0) to Week 52
measure: Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52
timeFrame: Baseline (Week 0) to Week 52
measure: Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12
timeFrame: Baseline (Week 0) to Week 12
measure: Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52
timeFrame: Baseline (Week 0) to Week 52
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12
timeFrame: Baseline (Week 0) to Week 12
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52
timeFrame: Baseline (Week 0) to Week 52
measure: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12
timeFrame: Baseline (Week 0) to Week 12
measure: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52
timeFrame: Baseline (Week 0) to Week 52
measure: Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12
timeFrame: Week 12
measure: Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52
timeFrame: Week 52
measure: Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12
timeFrame: Week 12
measure: Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52
timeFrame: Week 52
measure: Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12
timeFrame: Week 12
measure: Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52
timeFrame: Week 52
measure: Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12
timeFrame: Week 12
measure: Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52
timeFrame: Week 52
measure: Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12
timeFrame: Week 12
measure: Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52
timeFrame: Week 52
measure: Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12
timeFrame: Week 12
measure: Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52
timeFrame: Week 52
measure: Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
timeFrame: Week 12
measure: Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
timeFrame: Week 12
measure: Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
timeFrame: Week 12
measure: Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
timeFrame: Week 12
measure: Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
timeFrame: Week 12
measure: Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
timeFrame: Week 12
measure: Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
timeFrame: Week 12
measure: Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
timeFrame: Week 12
measure: Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
timeFrame: Week 52
measure: Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
timeFrame: Week 52
measure: Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
timeFrame: Week 52
measure: Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
timeFrame: Week 52
measure: Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
timeFrame: Week 52
measure: Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
timeFrame: Week 52
measure: Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
timeFrame: Week 52
measure: Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 137
state: Alabama
city: Huntsville
country: United States
facility: 166
state: Alabama
city: Peoria
country: United States
facility: 165
state: Arizona
city: Tucson
country: United States
facility: 216
state: Arizona
city: Hot Springs
country: United States
facility: 168
state: Arkansas
city: Jonesboro
country: United States
facility: 241
state: Arkansas
city: Little Rock
country: United States
facility: 153
state: Arkansas
city: Covina
country: United States
facility: 111
state: California
city: Escondido
country: United States
facility: 208
state: California
city: Fullerton
country: United States
facility: 103
state: California
city: Huntington Beach
country: United States
facility: 155
state: California
city: La Mesa
country: United States
facility: 202
state: California
city: Loma Linda
country: United States
facility: 203
state: California
city: Los Angeles
country: United States
facility: 233
state: California
city: Palm Desert
country: United States
facility: 105
state: California
city: Roseville
country: United States
facility: 229
state: California
city: Sacramento
country: United States
facility: 113
state: California
city: San Diego
country: United States
facility: 127
state: California
city: Santa Maria
country: United States
facility: 106
state: California
city: Santa Monica
country: United States
facility: 172
state: California
city: Upland
country: United States
facility: 212
state: California
city: Van Nuys
country: United States
facility: 231
state: California
city: Whittier
country: United States
facility: 158
state: California
city: Bridgeport
country: United States
facility: 121
state: Connecticut
city: Bridgeport
country: United States
facility: 200
state: Connecticut
city: Danbury
country: United States
facility: 107
state: Connecticut
city: Danbury
country: United States
facility: 195
state: Connecticut
city: Hamden
country: United States
facility: 138
state: Connecticut
city: Lewes
country: United States
facility: 218
state: Delaware
city: Aventura
country: United States
facility: 108
state: Florida
city: Dunedin
country: United States
facility: 120
state: Florida
city: Ocala
country: United States
facility: 101
state: Florida
city: Orange Park
country: United States
facility: 225
state: Florida
city: Ormond Beach
country: United States
facility: 227
state: Florida
city: Palm Harbor
country: United States
facility: 184
state: Florida
city: Sarasota
country: United States
facility: 145
state: Florida
city: Tampa
country: United States
facility: 191
state: Florida
city: Vero Beach
country: United States
facility: 236
state: Florida
city: Atlanta
country: United States
facility: 144
state: Georgia
city: Atlanta
country: United States
facility: 232
state: Georgia
city: Lawrenceville
country: United States
facility: 157
state: Georgia
city: Coeur d'Alene
country: United States
facility: 217
state: Idaho
city: Idaho Falls
country: United States
facility: 206
state: Idaho
city: Rock Island
country: United States
facility: 193
state: Illinois
city: Springfield
country: United States
facility: 207
state: Illinois
city: Elizabethtown
country: United States
facility: 186
state: Kentucky
city: Lexington
country: United States
facility: 204
state: Kentucky
city: Louisville
country: United States
facility: 230
state: Kentucky
city: Cumberland
country: United States
facility: 149
state: Maryland
city: Hagerstown
country: United States
facility: 237
state: Maryland
city: Wheaton
country: United States
facility: 197
state: Maryland
city: Mansfield
country: United States
facility: 118
state: Massachusetts
city: Worcester
country: United States
facility: 132
state: Massachusetts
city: Lansing
country: United States
facility: 140
state: Michigan
city: Petoskey
country: United States
facility: 226
state: Michigan
city: Saint Clair Shores
country: United States
facility: 114
state: Michigan
city: Bridgeton
country: United States
facility: 188
state: Missouri
city: Saint Louis
country: United States
facility: 109
state: Missouri
city: Saint Louis
country: United States
facility: 133
state: Missouri
city: Lincoln
country: United States
facility: 124
state: Nebraska
city: Reno
country: United States
facility: 205
state: Nevada
city: Lebanon
country: United States
facility: 159
state: New Hampshire
city: Nashua
country: United States
facility: 189
state: New Hampshire
city: Clifton
country: United States
facility: 143
state: New Jersey
city: Albuquerque
country: United States
facility: 125
state: New Mexico
city: Albany
country: United States
facility: 175
state: New York
city: Binghamton
country: United States
facility: 139
state: New York
city: Brooklyn
country: United States
facility: 116
state: New York
city: Brooklyn
country: United States
facility: 167
state: New York
city: Johnson City
country: United States
facility: 196
state: New York
city: New York
country: United States
facility: 174
state: New York
city: Orchard Park
country: United States
facility: 104
state: New York
city: Plainview
country: United States
facility: 135
state: New York
city: Rochester
country: United States
facility: 215
state: New York
city: Charlotte
country: United States
facility: 178
state: North Carolina
city: Durham
country: United States
facility: 210
state: North Carolina
city: Hickory
country: United States
facility: 234
state: North Carolina
city: Monroe
country: United States
facility: 102
state: North Carolina
city: Bethlehem
country: United States
facility: 152
state: Pennsylvania
city: Duncansville
country: United States
facility: 112
state: Pennsylvania
city: Erie
country: United States
facility: 219
state: Pennsylvania
city: Philadelphia
country: United States
facility: 128
state: Pennsylvania
city: Sellersville
country: United States
facility: 147
state: Pennsylvania
city: Willow Grove
country: United States
facility: 213
state: Pennsylvania
city: Wyomissing
country: United States
facility: 235
state: Pennsylvania
city: Charleston
country: United States
facility: 198
state: South Carolina
city: Columbia
country: United States
facility: 228
state: South Carolina
city: Hendersonville
country: United States
facility: 130
state: Tennessee
city: Jackson
country: United States
facility: 129
state: Tennessee
city: Amarillo
country: United States
facility: 162
state: Texas
city: Austin
country: United States
facility: 110
state: Texas
city: Austin
country: United States
facility: 156
state: Texas
city: Dallas
country: United States
facility: 192
state: Texas
city: El Paso
country: United States
facility: 185
state: Texas
city: Houston
country: United States
facility: 122
state: Texas
city: Houston
country: United States
facility: 170
state: Texas
city: Mesquite
country: United States
facility: 123
state: Texas
city: Nassau Bay
country: United States
facility: 115
state: Texas
city: San Antonio
country: United States
facility: 117
state: Texas
city: San Antonio
country: United States
facility: 119
state: Texas
city: San Antonio
country: United States
facility: 161
state: Texas
city: Victoria
country: United States
facility: 190
state: Texas
city: Waco
country: United States
facility: 142
state: Texas
city: Burlington
country: United States
facility: 136
state: Vermont
city: Arlington
country: United States
facility: 146
state: Virginia
city: Chesapeake
country: United States
facility: 150
state: Virginia
city: Kennewick
country: United States
facility: 223
state: Washington
city: Spokane
country: United States
facility: 134
state: Washington
city: Clarksburg
country: United States
facility: 221
state: West Virginia
city: Glendale
country: United States
facility: 194
state: Wisconsin
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Curtis JR, Herrem C, Ndlovu 'N, O'Brien C, Yazici Y. A somatization comorbidity phenotype impacts response to therapy in rheumatoid arthritis: post-hoc results from the certolizumab pegol phase 4 PREDICT trial. Arthritis Res Ther. 2017 Sep 29;19(1):215. doi: 10.1186/s13075-017-1412-z.
citation: Curtis JR, Churchill M, Kivitz A, Samad A, Gauer L, Gervitz L, Koetse W, Melin J, Yazici Y. A Randomized Trial Comparing Disease Activity Measures for the Assessment and Prediction of Response in Rheumatoid Arthritis Patients Initiating Certolizumab Pegol. Arthritis Rheumatol. 2015 Dec;67(12):3104-12. doi: 10.1002/art.39322.