A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis (C-early)

July 4, 2018 updated by: UCB Pharma SA

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis

This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

880

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • 276
      • Rosario, Argentina
        • 284
      • San Juan, Argentina
        • 279
      • Tucuman, Argentina
        • 291
  • Australia
    • New South Wales
      • Coffs Harbour, New South Wales, Australia
        • 6
    • Queensland
      • Herson, Queensland, Australia
        • 2
      • Maroochydore, Queensland, Australia
        • 1
    • South Australia
      • Woodville South, South Australia, Australia
        • 8
    • Victoria
      • Fitzroy, Victoria, Australia
        • 5
      • Geelong, Victoria, Australia
        • 4
      • Malvern, Victoria, Australia
        • 3
    • Western Australia
      • Perth, Western Australia, Australia
        • 7
  • Austria
      • Wien, Austria
        • 50
  • Belgium
      • Brussels, Belgium
        • 51
      • Gilly, Belgium
        • 126
      • Kortrijk, Belgium
        • 36
      • Yvoir, Belgium
        • 65
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
        • 240
    • Ontario
      • Hamilton, Ontario, Canada
        • 235
    • Quebec
      • Montreal, Quebec, Canada
        • 188
      • Trois-rivieres, Quebec, Canada
        • 194
  • Colombia
      • Barranquilla, Colombia
        • 303
      • Bogota, Colombia
        • 272
      • Bogota, Colombia
        • 293
      • Bogota, Colombia
        • 299
      • Bucaramanga, Colombia
        • 297
      • Chia, Colombia
        • 288
      • Medellin, Colombia
        • 271
      • Medellin, Colombia
        • 298
  • Czechia
      • Brno, Czechia
        • 108
      • Bruntal, Czechia
        • 124
      • Hradec Kralove, Czechia
        • 38
      • Praha, Czechia
        • 37
  • France
      • Le Kremlin Bicetre, France
        • 16
      • Le Mans, France
        • 85
      • Montpellier Cedex 5, France
        • 88
      • Orleans, France
        • 34
      • Strasbourg, France
        • 79
  • Germany
      • Bad Doberan, Germany
        • 52
      • Bayreuth, Germany
        • 17
      • Berlin, Germany
        • 113
      • Berlin, Germany
        • 120
      • Erfurt, Germany
        • 89
      • Frankfurt, Germany
        • 70
      • Hamburg, Germany
        • 71
      • Hildesheim, Germany
        • 81
      • Lingen, Germany
        • 127
      • München, Germany
        • 61
      • Planegg, Germany
        • 53
      • Ratingen, Germany
        • 132
      • Rendsburg, Germany
        • 49
      • Rheine, Germany
        • 69
      • Würzburg, Germany
        • 114
      • Zerbst, Germany
        • 59
  • Hungary
      • Budapest, Hungary
        • 18
      • Budapest, Hungary
        • 21
      • Eger, Hungary
        • 86
      • Szolnok, Hungary
        • 131
      • Szombathely, Hungary
        • 110
      • Veszprem, Hungary
        • 19
  • Ireland
      • Cork, Ireland
        • 33
      • Dublin, Ireland
        • 54
      • Limerick, Ireland
        • 32
  • Italy
      • Ferrara, Italy
        • 115
      • Milano, Italy
        • 122
      • Reggio Emilia, Italy
        • 40
      • Roma, Italy
        • 72
      • Verona, Italy
        • 41
  • Mexico
      • Durango, Mexico
        • 281
      • Guadalajara, Mexico
        • 286
      • Merida, Mexico
        • 302
      • Mexico City, Mexico
        • 292
      • Monterrey, Mexico
        • 280
      • San Luis Potosi, Mexico
        • 294
  • Monaco
      • Monaco, Monaco
        • 78
  • Netherlands
      • Leiden, Netherlands
        • 42
  • Poland
      • Bydgoszcz, Poland
        • 128
      • Elblag, Poland
        • 67
      • Krakow, Poland
        • 99
      • Poznan, Poland
        • 92
      • Torun, Poland
        • 74
      • Warszawa, Poland
        • 100
      • Wroclaw, Poland
        • 44
  • Romania
      • Brasov, Romania
        • 58
      • Bucharest, Romania
        • 111
      • Bucharest, Romania
        • 22
      • Bucharest, Romania
        • 25
      • Bucharest, Romania
        • 26
      • Iasi, Romania
        • 24
      • Lasi, Romania
        • 57
  • Spain
      • Coruna, Spain
        • 93
      • Madrid, Spain
        • 47
      • Santiago de Compostela, Spain
        • 63
  • Sweden
      • Göteborg, Sweden
        • 76
      • Huddinge, Sweden
        • 82
      • Lund, Sweden
        • 106
      • Malmö, Sweden
        • 123
      • Stockholm, Sweden
        • 77
      • Uppsala, Sweden
        • 75
  • Switzerland
      • Fribourg, Switzerland
        • 118
      • St. Gallen, Switzerland
        • 68
  • United Kingdom
      • Cannock, United Kingdom
        • 125
      • Dudley, United Kingdom
        • 105
      • Leeds, United Kingdom
        • 56
      • London, United Kingdom
        • 121
      • London, United Kingdom
        • 27
      • Sheffield, United Kingdom
        • 80
      • York, United Kingdom
        • 119
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 209
      • Huntsville, Alabama, United States
        • 170
      • Mobile, Alabama, United States
        • 180
    • Arizona
      • Glendale, Arizona, United States
        • 247
      • Paradise Valley, Arizona, United States
        • 165
      • Paradise Valley, Arizona, United States
        • 234
      • Phoenix, Arizona, United States
        • 243
      • Tucson, Arizona, United States
        • 251
    • California
      • Covina, California, United States
        • 160
      • Hemet, California, United States
        • 257
      • Los Angeles, California, United States
        • 159
      • San Leandro, California, United States
        • 201
      • Upland, California, United States
        • 202
      • Whittier, California, United States
        • 172
    • Florida
      • Fort Lauderdale, Florida, United States
        • 190
      • Jupiter, Florida, United States
        • 196
      • Lake Mary, Florida, United States
        • 238
      • Miami, Florida, United States
        • 232
      • Naples, Florida, United States
        • 213
      • Ocala, Florida, United States
        • 214
      • Orange Park, Florida, United States
        • 237
      • Orlando, Florida, United States
        • 255
      • Palm Harbor, Florida, United States
        • 163
      • Plantation, Florida, United States
        • 166
      • Sarasota, Florida, United States
        • 192
      • Vero Beach, Florida, United States
        • 200
    • Idaho
      • Coeur d'Alene, Idaho, United States
        • 226
    • Illinois
      • Springfield, Illinois, United States
        • 244
    • Indiana
      • South Bend, Indiana, United States
        • 224
    • Iowa
      • Cedar Rapids, Iowa, United States
        • 215
    • Kansas
      • Wichita, Kansas, United States
        • 191
      • Wichita, Kansas, United States
        • 210
    • Maryland
      • Hagerstown, Maryland, United States
        • 177
    • Michigan
      • Kalamazoo, Michigan, United States
        • 199
    • Minnesota
      • Eagan, Minnesota, United States
        • 198
    • Mississippi
      • Tupelo, Mississippi, United States
        • 203
    • Missouri
      • Saint Louis, Missouri, United States
        • 179
    • Nebraska
      • Lincoln, Nebraska, United States
        • 181
    • Nevada
      • Reno, Nevada, United States
        • 256
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • 229
    • New Jersey
      • Clifton, New Jersey, United States
        • 228
    • New Mexico
      • Albuquerque, New Mexico, United States
        • 207
    • New York
      • Brooklyn, New York, United States
        • 176
      • Plainview, New York, United States
        • 242
      • Rochester, New York, United States
        • 227
    • North Carolina
      • Durham, North Carolina, United States
        • 236
    • Ohio
      • Middleburg Heights, Ohio, United States
        • 245
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 241
    • Oregon
      • Portland, Oregon, United States
        • 186
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
        • 195
      • Duncansville, Pennsylvania, United States
        • 167
      • Wyomissing, Pennsylvania, United States
        • 168
    • South Carolina
      • Charleston, South Carolina, United States
        • 189
      • Columbia, South Carolina, United States
        • 205
    • Tennessee
      • Hendersonville, Tennessee, United States
        • 204
    • Texas
      • Allen, Texas, United States
        • 217
      • Amarillo, Texas, United States
        • 185
      • Austin, Texas, United States
        • 161
      • Corpus Christi, Texas, United States
        • 178
      • Dallas, Texas, United States
        • 162
      • Houston, Texas, United States
        • 184
      • Houston, Texas, United States
        • 206
      • Houston, Texas, United States
        • 223
      • Mesquite, Texas, United States
        • 158
      • Nassau Bay, Texas, United States
        • 175
      • Plano, Texas, United States
        • 249
      • San Antonio, Texas, United States
        • 197
    • Washington
      • Kennewick, Washington, United States
        • 233
    • West Virginia
      • Clarksburg, West Virginia, United States
        • 183
    • Wisconsin
      • Glendale, Wisconsin, United States
        • 174

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have a time since diagnosis of adult-onset Rheumatoid Arthritis (RA) less than 1 year as defined by the 2010 ACR/EULAR classification criteria from Screening Visit
  • Positive Rheumatoid Factor (RF) and/or positive anticyclic Citrullinated Peptide Antibody (anti-CCP)
  • Active RA disease
  • DMARD-naïve
  • Subject is naïve to RA related biologics

Exclusion Criteria:

  • A diagnosis of any other inflammatory Arthritis
  • History of infected joint prosthesis, or other significant infection and other serious medical condition
  • Known Tuberculosis (TB) disease or high risk of acquiring TB infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Certolizumab Pegol + Methotrexate
Biological: Certolizumab Pegol

Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.

Injections will be given subcutaneously. CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 50.

Other Names:
  • Cimzia
  • CZP
Biological: Methotrexate
The MTX treatment is to be initiated at a dose of 10 mg per Week (oral tablets at the strength of 2.5 mg/tablet). The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8. Patients who could not tolerate ≥ 15 mg/week MTX by Week 8 were withdrawn while the maximum tolerated dose per patient (optimized dose) was maintained to Week 52.
Other Names:
  • MTX
Placebo Comparator: Placebo + Methotrexate
Biological: Methotrexate
The MTX treatment is to be initiated at a dose of 10 mg per Week (oral tablets at the strength of 2.5 mg/tablet). The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8. Patients who could not tolerate ≥ 15 mg/week MTX by Week 8 were withdrawn while the maximum tolerated dose per patient (optimized dose) was maintained to Week 52.
Other Names:
  • MTX
Other: Placebo
2 syringes Placebo at Baseline, Week 2 and Week 4, followed by 1 syringe Placebo every 2 Weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects in Sustained Remission at Week 52
Time Frame: Week 52

Sustained remission is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at both Weeks 40 and 52.

DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:

0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects in Sustained Low Disease Activity (LDA) at Week 52
Time Frame: Week 52
Sustained LDA is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) ≤ 3.2 at both Weeks 40 and 52.
Week 52
Change From Baseline in Modified Total Sharp Score (mTSS) to Week 52
Time Frame: From Baseline (Week 0) to Week 52
Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.
From Baseline (Week 0) to Week 52
Percentage of Subjects With Radiographic Non-progression From Baseline to Week 52
Time Frame: From Baseline (Week 0) to Week 52
Radiographic non-progression is defined as change in mTSS ≤ 0.5.
From Baseline (Week 0) to Week 52
Change From Baseline in the Joint Erosion Score to Week 52
Time Frame: From Baseline (Week 0) to Week 52

Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.

The maximum possible erosion score for all 32-hand joints was 160. The maximum possible erosion score for all 12 feet joints was 120. Thus, the maximum possible total erosion score for hands and feet was 280.
From Baseline (Week 0) to Week 52
Change From Baseline in the Joint Narrowing Score to Week 52
Time Frame: From Baseline (Week 0) to Week 52
Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The maximum possible score for JSN in all 30 hand joints was 120. The maximum possible score for JSN in all 12 feet joints was 48. Thus, the maximum possible total JSN score for Hands and feet was 168.
From Baseline (Week 0) to Week 52
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52
Time Frame: From Baseline (Week 0) to Week 52
The assessments are based on a 20 % or greater improvement from Baseline in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
From Baseline (Week 0) to Week 52
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52
Time Frame: From Baseline (Week 0) to Week 52
The assessments are based on a 50 % or greater improvement from Baseline in the number of tender joints, a 50 %, or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
From Baseline (Week 0) to Week 52
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52
Time Frame: From Baseline (Week 0) to Week 52
The assessments are based on a 70 % or greater improvement from Baseline in the number of tender joints, a 70 %, or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
From Baseline (Week 0) to Week 52
Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 52
Time Frame: Week 52

The ACR/EULAR 2011 remission criteria is defined as:

Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1, C-reactive protein (CRP) ≤ 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1.
Week 52
Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52
Time Frame: Week 52
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.
Week 52
Percentage of Subjects With Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52
Time Frame: Week 52
SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.
Week 52
Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52
Time Frame: Week 52

DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:

0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.
Week 52
Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 52
Time Frame: Week 52

The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:

Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1 and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1.
Week 52
Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 52
Time Frame: From Baseline (Week 0) to Week 52

Good response is defined as:

DAS28[ESR] ≤ 3.2 and decrease from Baseline by > 1.2;

moderate response is defined as achievement of one of the following:

  • DAS28[ESR] ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2
  • DAS28[ESR] > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6
  • DAS28[ESR] > 5.1 and decrease from Baseline >1.2.
From Baseline (Week 0) to Week 52
Change From Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52
Time Frame: From Baseline (Week 0) to Week 52

DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:

0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.
From Baseline (Week 0) to Week 52
Change From Baseline in Clinical Disease Activity Index (CDAI) to Week 52
Time Frame: From 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 - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.

The CDAI score ranges from 0 to 76, with a negative value in CDAI change from Baseline indicating an improvement from Baseline.
From Baseline (Week 0) to Week 52
Change From Baseline in Simplified Disease Activity Index (SDAI) to Week 52
Time Frame: From Baseline (Week 0) to Week 52

SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.

The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline.
From Baseline (Week 0) to Week 52
Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52
Time Frame: Week 52

Normative physical function is defined as HAQ-DI score ≤ 0.5. The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.

The total score ranges from 0 to 3 with lower scores meaning lower disability.
Week 52
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52
Time Frame: From Baseline (Week 0) to Week 52

The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.

The total score ranges from 0 (no difficulty) to 3 (unable to do) with lower scores meaning lower disability.

A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline.
From Baseline (Week 0) to Week 52
Change From Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 52
Time Frame: From Baseline (Week 0) to Week 52

BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue).

A negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline.
From Baseline (Week 0) to Week 52
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Time Frame: Week 52
Number of work days missed in the last month for employed subjects.
Week 52
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Time Frame: Week 52
Number of work days with reduced productivity in the last month for employed subjects.
Week 52
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Time Frame: 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) for employed subjects.
Week 52
Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Time Frame: Week 52
Number of days with no household work in the last month.
Week 52
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Time Frame: Week 52
Number of days with reduced household work productivity in the last month.
Week 52
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Time Frame: Week 52
Number of days with hired outside help in the last month.
Week 52
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Time Frame: Week 52
Number of days missed of family/social/leisure activities in the last month.
Week 52
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Time Frame: 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).
Week 52
Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 52
Time Frame: Week 52
LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 19, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 27, 2012

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA0055 Period 1
  • 2011-001729-25 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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