A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects
PREDICT
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
1 other identifier
interventional
736
1 country
110
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 rheumatoid-arthritis
Started Nov 2010
110 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
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 6, 2010
CompletedFirst Posted
Study publicly available on registry
December 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
March 7, 2014
CompletedJuly 31, 2018
March 1, 2018
1.9 years
December 6, 2010
October 7, 2013
July 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]
For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. CDAI is the sum of tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - VAS (VAS in cm). 28 joints are examined. RAPID3 is the sum of the MDHAQ subscores of physical function, pain, and patient's global status.
Baseline (Week 0) to Week 12
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
For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.
Baseline (Week 0) to Week 52
Secondary Outcomes (37)
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
Baseline (Week 0) to Week 52
Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52
Baseline (Week 0) to Week 52
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
Baseline (Week 0) to Week 52
Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12
Baseline (Week 0) to Week 12
Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52
Baseline (Week 0) to Week 52
- +32 more secondary outcomes
Study Arms (2)
RAPID3 to assess response to Cimzia
OTHERRAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
CDAI to assess response to Cimzia
OTHERCDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
Interventions
400 mg subcutaneous injection at Weeks 0, 2 and 4 200 mg subcutaneous injection every two weeks, Week 6 through Week 52
Eligibility Criteria
You may qualify if:
- 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:
- tender joints (28 joint count) at Screening and Baseline Visits; and
- 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)
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (110)
137
Birmingham, Alabama, United States
166
Huntsville, Alabama, United States
165
Peoria, Arizona, United States
216
Tucson, Arizona, United States
168
Hot Springs, Arkansas, United States
241
Jonesboro, Arkansas, United States
153
Little Rock, Arkansas, United States
111
Covina, California, United States
208
Escondido, California, United States
103
Fullerton, California, United States
155
Huntington Beach, California, United States
202
La Mesa, California, United States
203
Loma Linda, California, United States
233
Los Angeles, California, United States
105
Palm Desert, California, United States
229
Roseville, California, United States
113
Sacramento, California, United States
127
San Diego, California, United States
106
Santa Maria, California, United States
172
Santa Monica, California, United States
212
Upland, California, United States
231
Van Nuys, California, United States
158
Whittier, California, United States
121
Bridgeport, Connecticut, United States
200
Bridgeport, Connecticut, United States
107
Danbury, Connecticut, United States
195
Danbury, Connecticut, United States
138
Hamden, Connecticut, United States
218
Lewes, Delaware, United States
108
Aventura, Florida, United States
120
Dunedin, Florida, United States
101
Ocala, Florida, United States
225
Orange Park, Florida, United States
227
Ormond Beach, Florida, United States
184
Palm Harbor, Florida, United States
145
Sarasota, Florida, United States
191
Tampa, Florida, United States
236
Vero Beach, Florida, United States
144
Atlanta, Georgia, United States
232
Atlanta, Georgia, United States
157
Lawrenceville, Georgia, United States
217
Coeur d'Alene, Idaho, United States
206
Idaho Falls, Idaho, United States
193
Rock Island, Illinois, United States
207
Springfield, Illinois, United States
186
Elizabethtown, Kentucky, United States
204
Lexington, Kentucky, United States
230
Louisville, Kentucky, United States
149
Cumberland, Maryland, United States
237
Hagerstown, Maryland, United States
197
Wheaton, Maryland, United States
118
Mansfield, Massachusetts, United States
132
Worcester, Massachusetts, United States
140
Lansing, Michigan, United States
226
Petoskey, Michigan, United States
114
Saint Clair Shores, Michigan, United States
188
Bridgeton, Missouri, United States
109
St Louis, Missouri, United States
133
St Louis, Missouri, United States
124
Lincoln, Nebraska, United States
205
Reno, Nevada, United States
159
Lebanon, New Hampshire, United States
189
Nashua, New Hampshire, United States
143
Clifton, New Jersey, United States
125
Albuquerque, New Mexico, United States
175
Albany, New York, United States
139
Binghamton, New York, United States
116
Brooklyn, New York, United States
167
Brooklyn, New York, United States
196
Johnson City, New York, United States
174
New York, New York, United States
104
Orchard Park, New York, United States
135
Plainview, New York, United States
215
Rochester, New York, United States
178
Charlotte, North Carolina, United States
210
Durham, North Carolina, United States
234
Hickory, North Carolina, United States
102
Monroe, North Carolina, United States
152
Bethlehem, Pennsylvania, United States
112
Duncansville, Pennsylvania, United States
219
Erie, Pennsylvania, United States
128
Philadelphia, Pennsylvania, United States
147
Sellersville, Pennsylvania, United States
213
Willow Grove, Pennsylvania, United States
235
Wyomissing, Pennsylvania, United States
198
Charleston, South Carolina, United States
228
Columbia, South Carolina, United States
130
Hendersonville, Tennessee, United States
129
Jackson, Tennessee, United States
162
Amarillo, Texas, United States
110
Austin, Texas, United States
156
Austin, Texas, United States
192
Dallas, Texas, United States
185
El Paso, Texas, United States
122
Houston, Texas, United States
170
Houston, Texas, United States
123
Mesquite, Texas, United States
115
Nassau Bay, Texas, United States
117
San Antonio, Texas, United States
119
San Antonio, Texas, United States
161
San Antonio, Texas, United States
190
Victoria, Texas, United States
142
Waco, Texas, United States
136
Burlington, Vermont, United States
146
Arlington, Virginia, United States
150
Chesapeake, Virginia, United States
223
Kennewick, Washington, United States
134
Spokane, Washington, United States
221
Clarksburg, West Virginia, United States
194
Glendale, Wisconsin, United States
Related Publications (2)
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.
PMID: 28962590RESULTCurtis 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.
PMID: 26316013DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- (UCB) Study Director
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- 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
December 6, 2010
First Posted
December 7, 2010
Study Start
November 1, 2010
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
July 31, 2018
Results First Posted
March 7, 2014
Record last verified: 2018-03