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

4 juli 2018 bijgewerkt door: 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

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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)

Studietype

Ingrijpend

Inschrijving (Werkelijk)

736

Fase

  • Fase 4

Uitgebreide toegang

Verkrijgbaar buiten de klinische proef. Zie uitgebreid toegangsrecord.

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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
Biologisch: 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

Andere namen:
  • Cimzia
Ander: 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)
Biologisch: 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

Andere namen:
  • Cimzia

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

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Sponsor

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Publicaties en nuttige links

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Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2010

Primaire voltooiing (Werkelijk)

1 oktober 2012

Studie voltooiing (Werkelijk)

1 december 2012

Studieregistratiedata

Eerst ingediend

6 december 2010

Eerst ingediend dat voldeed aan de QC-criteria

6 december 2010

Eerst geplaatst (Schatting)

7 december 2010

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 juli 2018

Laatste update ingediend die voldeed aan QC-criteria

4 juli 2018

Laatst geverifieerd

1 maart 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RA0064

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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