Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects (PREDICT)

4 luglio 2018 aggiornato da: UCB Pharma

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

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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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)

Tipo di studio

Interventistico

Iscrizione (Effettivo)

736

Fase

  • Fase 4

Accesso esteso

A disposizione al di fuori della sperimentazione clinica. Vedi record di accesso esteso.

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti
        • 137
      • Huntsville, Alabama, Stati Uniti
        • 166
    • Arizona
      • Peoria, Arizona, Stati Uniti
        • 165
      • Tucson, Arizona, Stati Uniti
        • 216
    • Arkansas
      • Hot Springs, Arkansas, Stati Uniti
        • 168
      • Jonesboro, Arkansas, Stati Uniti
        • 241
      • Little Rock, Arkansas, Stati Uniti
        • 153
    • California
      • Covina, California, Stati Uniti
        • 111
      • Escondido, California, Stati Uniti
        • 208
      • Fullerton, California, Stati Uniti
        • 103
      • Huntington Beach, California, Stati Uniti
        • 155
      • La Mesa, California, Stati Uniti
        • 202
      • Loma Linda, California, Stati Uniti
        • 203
      • Los Angeles, California, Stati Uniti
        • 233
      • Palm Desert, California, Stati Uniti
        • 105
      • Roseville, California, Stati Uniti
        • 229
      • Sacramento, California, Stati Uniti
        • 113
      • San Diego, California, Stati Uniti
        • 127
      • Santa Maria, California, Stati Uniti
        • 106
      • Santa Monica, California, Stati Uniti
        • 172
      • Upland, California, Stati Uniti
        • 212
      • Van Nuys, California, Stati Uniti
        • 231
      • Whittier, California, Stati Uniti
        • 158
    • Connecticut
      • Bridgeport, Connecticut, Stati Uniti
        • 121
      • Bridgeport, Connecticut, Stati Uniti
        • 200
      • Danbury, Connecticut, Stati Uniti
        • 107
      • Danbury, Connecticut, Stati Uniti
        • 195
      • Hamden, Connecticut, Stati Uniti
        • 138
    • Delaware
      • Lewes, Delaware, Stati Uniti
        • 218
    • Florida
      • Aventura, Florida, Stati Uniti
        • 108
      • Dunedin, Florida, Stati Uniti
        • 120
      • Ocala, Florida, Stati Uniti
        • 101
      • Orange Park, Florida, Stati Uniti
        • 225
      • Ormond Beach, Florida, Stati Uniti
        • 227
      • Palm Harbor, Florida, Stati Uniti
        • 184
      • Sarasota, Florida, Stati Uniti
        • 145
      • Tampa, Florida, Stati Uniti
        • 191
      • Vero Beach, Florida, Stati Uniti
        • 236
    • Georgia
      • Atlanta, Georgia, Stati Uniti
        • 144
      • Atlanta, Georgia, Stati Uniti
        • 232
      • Lawrenceville, Georgia, Stati Uniti
        • 157
    • Idaho
      • Coeur d'Alene, Idaho, Stati Uniti
        • 217
      • Idaho Falls, Idaho, Stati Uniti
        • 206
    • Illinois
      • Rock Island, Illinois, Stati Uniti
        • 193
      • Springfield, Illinois, Stati Uniti
        • 207
    • Kentucky
      • Elizabethtown, Kentucky, Stati Uniti
        • 186
      • Lexington, Kentucky, Stati Uniti
        • 204
      • Louisville, Kentucky, Stati Uniti
        • 230
    • Maryland
      • Cumberland, Maryland, Stati Uniti
        • 149
      • Hagerstown, Maryland, Stati Uniti
        • 237
      • Wheaton, Maryland, Stati Uniti
        • 197
    • Massachusetts
      • Mansfield, Massachusetts, Stati Uniti
        • 118
      • Worcester, Massachusetts, Stati Uniti
        • 132
    • Michigan
      • Lansing, Michigan, Stati Uniti
        • 140
      • Petoskey, Michigan, Stati Uniti
        • 226
      • Saint Clair Shores, Michigan, Stati Uniti
        • 114
    • Missouri
      • Bridgeton, Missouri, Stati Uniti
        • 188
      • Saint Louis, Missouri, Stati Uniti
        • 109
      • Saint Louis, Missouri, Stati Uniti
        • 133
    • Nebraska
      • Lincoln, Nebraska, Stati Uniti
        • 124
    • Nevada
      • Reno, Nevada, Stati Uniti
        • 205
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti
        • 159
      • Nashua, New Hampshire, Stati Uniti
        • 189
    • New Jersey
      • Clifton, New Jersey, Stati Uniti
        • 143
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti
        • 125
    • New York
      • Albany, New York, Stati Uniti
        • 175
      • Binghamton, New York, Stati Uniti
        • 139
      • Brooklyn, New York, Stati Uniti
        • 116
      • Brooklyn, New York, Stati Uniti
        • 167
      • Johnson City, New York, Stati Uniti
        • 196
      • New York, New York, Stati Uniti
        • 174
      • Orchard Park, New York, Stati Uniti
        • 104
      • Plainview, New York, Stati Uniti
        • 135
      • Rochester, New York, Stati Uniti
        • 215
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti
        • 178
      • Durham, North Carolina, Stati Uniti
        • 210
      • Hickory, North Carolina, Stati Uniti
        • 234
      • Monroe, North Carolina, Stati Uniti
        • 102
    • Pennsylvania
      • Bethlehem, Pennsylvania, Stati Uniti
        • 152
      • Duncansville, Pennsylvania, Stati Uniti
        • 112
      • Erie, Pennsylvania, Stati Uniti
        • 219
      • Philadelphia, Pennsylvania, Stati Uniti
        • 128
      • Sellersville, Pennsylvania, Stati Uniti
        • 147
      • Willow Grove, Pennsylvania, Stati Uniti
        • 213
      • Wyomissing, Pennsylvania, Stati Uniti
        • 235
    • South Carolina
      • Charleston, South Carolina, Stati Uniti
        • 198
      • Columbia, South Carolina, Stati Uniti
        • 228
    • Tennessee
      • Hendersonville, Tennessee, Stati Uniti
        • 130
      • Jackson, Tennessee, Stati Uniti
        • 129
    • Texas
      • Amarillo, Texas, Stati Uniti
        • 162
      • Austin, Texas, Stati Uniti
        • 110
      • Austin, Texas, Stati Uniti
        • 156
      • Dallas, Texas, Stati Uniti
        • 192
      • El Paso, Texas, Stati Uniti
        • 185
      • Houston, Texas, Stati Uniti
        • 122
      • Houston, Texas, Stati Uniti
        • 170
      • Mesquite, Texas, Stati Uniti
        • 123
      • Nassau Bay, Texas, Stati Uniti
        • 115
      • San Antonio, Texas, Stati Uniti
        • 117
      • San Antonio, Texas, Stati Uniti
        • 119
      • San Antonio, Texas, Stati Uniti
        • 161
      • Victoria, Texas, Stati Uniti
        • 190
      • Waco, Texas, Stati Uniti
        • 142
    • Vermont
      • Burlington, Vermont, Stati Uniti
        • 136
    • Virginia
      • Arlington, Virginia, Stati Uniti
        • 146
      • Chesapeake, Virginia, Stati Uniti
        • 150
    • Washington
      • Kennewick, Washington, Stati Uniti
        • 223
      • Spokane, Washington, Stati Uniti
        • 134
    • West Virginia
      • Clarksburg, West Virginia, Stati Uniti
        • 221
    • Wisconsin
      • Glendale, Wisconsin, Stati Uniti
        • 194

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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
Biologico: Certolizumab Pegol (CZP)

400 mg subcutaneous injection at Weeks 0, 2 and 4

200 mg subcutaneous injection every two weeks, Week 6 through Week 52

Altri nomi:
  • Cimzia
Altro: 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)
Biologico: Certolizumab Pegol (CZP)

400 mg subcutaneous injection at Weeks 0, 2 and 4

200 mg subcutaneous injection every two weeks, Week 6 through Week 52

Altri nomi:
  • Cimzia

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Lasso di tempo: 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
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Lasso di tempo: 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
Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

UCB Pharma

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2010

Completamento primario (Effettivo)

1 ottobre 2012

Completamento dello studio (Effettivo)

1 dicembre 2012

Date di iscrizione allo studio

Primo inviato

6 dicembre 2010

Primo inviato che soddisfa i criteri di controllo qualità

6 dicembre 2010

Primo Inserito (Stima)

7 dicembre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 luglio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 luglio 2018

Ultimo verificato

1 marzo 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RA0064

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi