- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01255761
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Acceso ampliado
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos
- 137
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Huntsville, Alabama, Estados Unidos
- 166
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Arizona
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Peoria, Arizona, Estados Unidos
- 165
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Tucson, Arizona, Estados Unidos
- 216
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Arkansas
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Hot Springs, Arkansas, Estados Unidos
- 168
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Jonesboro, Arkansas, Estados Unidos
- 241
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Little Rock, Arkansas, Estados Unidos
- 153
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California
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Covina, California, Estados Unidos
- 111
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Escondido, California, Estados Unidos
- 208
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Fullerton, California, Estados Unidos
- 103
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Huntington Beach, California, Estados Unidos
- 155
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La Mesa, California, Estados Unidos
- 202
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Loma Linda, California, Estados Unidos
- 203
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Los Angeles, California, Estados Unidos
- 233
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Palm Desert, California, Estados Unidos
- 105
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Roseville, California, Estados Unidos
- 229
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Sacramento, California, Estados Unidos
- 113
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San Diego, California, Estados Unidos
- 127
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Santa Maria, California, Estados Unidos
- 106
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Santa Monica, California, Estados Unidos
- 172
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Upland, California, Estados Unidos
- 212
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Van Nuys, California, Estados Unidos
- 231
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Whittier, California, Estados Unidos
- 158
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Connecticut
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Bridgeport, Connecticut, Estados Unidos
- 121
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Bridgeport, Connecticut, Estados Unidos
- 200
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Danbury, Connecticut, Estados Unidos
- 107
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Danbury, Connecticut, Estados Unidos
- 195
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Hamden, Connecticut, Estados Unidos
- 138
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Delaware
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Lewes, Delaware, Estados Unidos
- 218
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Florida
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Aventura, Florida, Estados Unidos
- 108
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Dunedin, Florida, Estados Unidos
- 120
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Ocala, Florida, Estados Unidos
- 101
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Orange Park, Florida, Estados Unidos
- 225
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Ormond Beach, Florida, Estados Unidos
- 227
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Palm Harbor, Florida, Estados Unidos
- 184
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Sarasota, Florida, Estados Unidos
- 145
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Tampa, Florida, Estados Unidos
- 191
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Vero Beach, Florida, Estados Unidos
- 236
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Georgia
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Atlanta, Georgia, Estados Unidos
- 144
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Atlanta, Georgia, Estados Unidos
- 232
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Lawrenceville, Georgia, Estados Unidos
- 157
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Idaho
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Coeur d'Alene, Idaho, Estados Unidos
- 217
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Idaho Falls, Idaho, Estados Unidos
- 206
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Illinois
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Rock Island, Illinois, Estados Unidos
- 193
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Springfield, Illinois, Estados Unidos
- 207
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Kentucky
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Elizabethtown, Kentucky, Estados Unidos
- 186
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Lexington, Kentucky, Estados Unidos
- 204
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Louisville, Kentucky, Estados Unidos
- 230
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Maryland
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Cumberland, Maryland, Estados Unidos
- 149
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Hagerstown, Maryland, Estados Unidos
- 237
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Wheaton, Maryland, Estados Unidos
- 197
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Massachusetts
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Mansfield, Massachusetts, Estados Unidos
- 118
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Worcester, Massachusetts, Estados Unidos
- 132
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Michigan
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Lansing, Michigan, Estados Unidos
- 140
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Petoskey, Michigan, Estados Unidos
- 226
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Saint Clair Shores, Michigan, Estados Unidos
- 114
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Missouri
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Bridgeton, Missouri, Estados Unidos
- 188
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Saint Louis, Missouri, Estados Unidos
- 109
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Saint Louis, Missouri, Estados Unidos
- 133
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Nebraska
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Lincoln, Nebraska, Estados Unidos
- 124
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Nevada
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Reno, Nevada, Estados Unidos
- 205
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos
- 159
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Nashua, New Hampshire, Estados Unidos
- 189
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New Jersey
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Clifton, New Jersey, Estados Unidos
- 143
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New Mexico
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Albuquerque, New Mexico, Estados Unidos
- 125
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New York
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Albany, New York, Estados Unidos
- 175
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Binghamton, New York, Estados Unidos
- 139
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Brooklyn, New York, Estados Unidos
- 116
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Brooklyn, New York, Estados Unidos
- 167
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Johnson City, New York, Estados Unidos
- 196
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New York, New York, Estados Unidos
- 174
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Orchard Park, New York, Estados Unidos
- 104
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Plainview, New York, Estados Unidos
- 135
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Rochester, New York, Estados Unidos
- 215
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North Carolina
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Charlotte, North Carolina, Estados Unidos
- 178
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Durham, North Carolina, Estados Unidos
- 210
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Hickory, North Carolina, Estados Unidos
- 234
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Monroe, North Carolina, Estados Unidos
- 102
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Pennsylvania
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Bethlehem, Pennsylvania, Estados Unidos
- 152
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Duncansville, Pennsylvania, Estados Unidos
- 112
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Erie, Pennsylvania, Estados Unidos
- 219
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Philadelphia, Pennsylvania, Estados Unidos
- 128
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Sellersville, Pennsylvania, Estados Unidos
- 147
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Willow Grove, Pennsylvania, Estados Unidos
- 213
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Wyomissing, Pennsylvania, Estados Unidos
- 235
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South Carolina
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Charleston, South Carolina, Estados Unidos
- 198
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Columbia, South Carolina, Estados Unidos
- 228
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Tennessee
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Hendersonville, Tennessee, Estados Unidos
- 130
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Jackson, Tennessee, Estados Unidos
- 129
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Texas
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Amarillo, Texas, Estados Unidos
- 162
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Austin, Texas, Estados Unidos
- 110
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Austin, Texas, Estados Unidos
- 156
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Dallas, Texas, Estados Unidos
- 192
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El Paso, Texas, Estados Unidos
- 185
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Houston, Texas, Estados Unidos
- 122
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Houston, Texas, Estados Unidos
- 170
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Mesquite, Texas, Estados Unidos
- 123
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Nassau Bay, Texas, Estados Unidos
- 115
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San Antonio, Texas, Estados Unidos
- 117
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San Antonio, Texas, Estados Unidos
- 119
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San Antonio, Texas, Estados Unidos
- 161
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Victoria, Texas, Estados Unidos
- 190
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Waco, Texas, Estados Unidos
- 142
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Vermont
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Burlington, Vermont, Estados Unidos
- 136
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Virginia
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Arlington, Virginia, Estados Unidos
- 146
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Chesapeake, Virginia, Estados Unidos
- 150
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Washington
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Kennewick, Washington, Estados Unidos
- 223
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Spokane, Washington, Estados Unidos
- 134
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West Virginia
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Clarksburg, West Virginia, Estados Unidos
- 221
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Wisconsin
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Glendale, Wisconsin, Estados Unidos
- 194
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: RAPID3 to assess response to Cimzia
RAPID3 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 |
400 mg subcutaneous injection at Weeks 0, 2 and 4 200 mg subcutaneous injection every two weeks, Week 6 through Week 52
Otros nombres:
|
Otro: CDAI to assess response to Cimzia
CDAI 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) |
400 mg subcutaneous injection at Weeks 0, 2 and 4 200 mg subcutaneous injection every two weeks, Week 6 through Week 52
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]
Periodo de tiempo: Baseline (Week 0) to Week 12
|
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
Periodo de tiempo: Baseline (Week 0) to 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
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
Periodo de tiempo: Baseline (Week 0) to 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
|
Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52
Periodo de tiempo: Baseline (Week 0) to 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
|
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
Periodo de tiempo: Baseline (Week 0) to 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
|
Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12
Periodo de tiempo: Baseline (Week 0) to Week 12
|
The DAS28(ESR) score is a measure of the subject's disease activity. DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity. |
Baseline (Week 0) to Week 12
|
Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52
Periodo de tiempo: Baseline (Week 0) to Week 52
|
The DAS28(ESR) score is a measure of the subject's disease activity. DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity. |
Baseline (Week 0) to Week 52
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12
Periodo de tiempo: Baseline (Week 0) to Week 12
|
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), 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 - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. |
Baseline (Week 0) to Week 12
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52
Periodo de tiempo: Baseline (Week 0) to Week 52
|
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), 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 - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. |
Baseline (Week 0) to Week 52
|
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12
Periodo de tiempo: Baseline (Week 0) to Week 12
|
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. |
Baseline (Week 0) to Week 12
|
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52
Periodo de tiempo: Baseline (Week 0) to Week 52
|
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. |
Baseline (Week 0) to Week 52
|
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12
Periodo de tiempo: Week 12
|
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined.
Lower scores indicate less disease activity.
|
Week 12
|
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52
Periodo de tiempo: Week 52
|
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined.
Lower scores indicate less disease activity.
|
Week 52
|
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12
Periodo de tiempo: Week 12
|
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined.
Lower scores indicate less disease activity.
|
Week 12
|
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52
Periodo de tiempo: Week 52
|
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined.
Lower scores indicate less disease activity.
|
Week 52
|
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12
Periodo de tiempo: Week 12
|
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), 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 - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. |
Week 12
|
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52
Periodo de tiempo: Week 52
|
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), 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 - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. |
Week 52
|
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12
Periodo de tiempo: Week 12
|
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), 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 - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. |
Week 12
|
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52
Periodo de tiempo: Week 52
|
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), 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 - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. |
Week 52
|
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12
Periodo de tiempo: Week 12
|
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. |
Week 12
|
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52
Periodo de tiempo: Week 52
|
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. |
Week 52
|
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12
Periodo de tiempo: Week 12
|
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. |
Week 12
|
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52
Periodo de tiempo: Week 52
|
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. |
Week 52
|
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Periodo de tiempo: Week 12
|
Number of work days missed in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
|
Week 12
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Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Periodo de tiempo: Week 12
|
Number of work days with reduced productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
|
Week 12
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Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Periodo de tiempo: Week 12
|
The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
|
Week 12
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Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Periodo de tiempo: Week 12
|
Number of days with no household work in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
|
Week 12
|
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Periodo de tiempo: Week 12
|
Number of days with reduced household work productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
|
Week 12
|
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Periodo de tiempo: Week 12
|
Number of days missed of family/social/leisure activities in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
|
Week 12
|
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Periodo de tiempo: Week 12
|
Number of days with hired outside help in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
|
Week 12
|
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Periodo de tiempo: Week 12
|
The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. |
Week 12
|
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Periodo de tiempo: Week 52
|
Number of work days missed in the last month.
The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
|
Week 52
|
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Periodo de tiempo: Week 52
|
Number of work days with reduced productivity in the last month.
The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
|
Week 52
|
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Periodo de tiempo: Week 52
|
The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. |
Week 52
|
Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Periodo de tiempo: Week 52
|
Number of days with no household work in the last month.
The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
|
Week 52
|
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Periodo de tiempo: Week 52
|
Number of days with reduced household work productivity in the last month.
The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
|
Week 52
|
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Periodo de tiempo: Week 52
|
Number of days missed of family/social/leisure activities in the last month.
The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
|
Week 52
|
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Periodo de tiempo: Week 52
|
Number of days with hired outside help in the last month.
The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
|
Week 52
|
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Periodo de tiempo: Week 52
|
The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity. |
Week 52
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Enfermedades autoinmunes
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades reumáticas
- Enfermedades del tejido conectivo
- Artritis
- Artritis Reumatoide
- Efectos fisiológicos de las drogas
- Agentes antirreumáticos
- Agentes inmunosupresores
- Factores inmunológicos
- Certolizumab Pegol
Otros números de identificación del estudio
- RA0064
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Certolizumab Pegol (CZP)
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