Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

A Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate

This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: Certolizumab Pegol (CZP); Drug: Methotrexate (MTX); Biological: Adalimumab (ADA)

• Study Type: Interventional
• Enrollment (Actual): 915
• Phase: Phase 4

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia
      • 6
    • Kogarah, New South Wales, Australia
      • 5
  • Queensland
    • Maroochydore, Queensland, Australia
      • 2
  • Tasmania
    • Hobart, Tasmania, Australia
      • 4
  • Victoria
    • Clayton, Victoria, Australia
      • 7
    • Fitzroy, Victoria, Australia
      • 8
    • Malvern, Victoria, Australia
      • 1
  • Western Australia
    • Subiaco, Western Australia, Australia
      • 3
• Austria
  • Stockerau, Austria
    • 85
  • Wien, Austria
    • 22
• Bulgaria
  • Pleven, Bulgaria
    • 18
  • Plovdiv, Bulgaria
    • 35
  • Sofia, Bulgaria
    • 21
  • Sofia, Bulgaria
    • 29
  • Sofia, Bulgaria
    • 34
  • Sofia, Bulgaria
    • 46
• Canada
  • Barrie, Canada
    • 221
  • Quebec, Canada
    • 171
  • Alberta
    • Edmonton, Alberta, Canada
      • 179
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada
      • 168
    • St. John's, Newfoundland and Labrador, Canada
      • 176
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • 183
  • Ontario
    • Hamilton, Ontario, Canada
      • 172
    • Hamilton, Ontario, Canada
      • 174
    • Ottawa, Ontario, Canada
      • 177
    • Ottawa, Ontario, Canada
      • 206
    • St. Catharines, Ontario, Canada
      • 175
  • Quebec
    • Rimouski, Quebec, Canada
      • 218
    • Sainte Foy, Quebec, Canada
      • 169
• Czechia
  • Brno, Czechia
    • 103
  • Hradec Kralove, Czechia
    • 61
  • Plzen, Czechia
    • 58
  • Praha, Czechia
    • 49
  • Uherske Hradiste, Czechia
    • 40
• France
  • Brest, France
    • 89
  • Le Mans, France
    • 70
  • Lyon, France
    • 62
  • Montpellier Cedex 5, France
    • 72
  • Orleans, France
    • 90
  • Toulouse Cedex 9, France
    • 105
• Germany
  • Berlin, Germany
    • 56
  • Fulda, Germany
    • 47
  • Hamburg, Germany
    • 17
  • Heidelberg, Germany
    • 31
  • Herne, Germany
    • 37
  • Köln, Germany
    • 64
  • Osnabrück, Germany
    • 63
  • Ratingen, Germany
    • 11
  • Rheine, Germany
    • 66
  • Rostock, Germany
    • 48
  • Traunstein, Germany
    • 71
  • Zerbst, Germany
    • 44
• Greece
  • Heraklion, Greece
    • 94
  • Larisa, Greece
    • 95
• Hungary
  • Budapest, Hungary
    • 13
  • Budapest, Hungary
    • 42
  • Gyula, Hungary
    • 68
  • Kistarcsa, Hungary
    • 100
  • Szeged, Hungary
    • 43
  • Veszprem, Hungary
    • 33
• Ireland
  • Dublin, Ireland
    • 23
  • Dublin, Ireland
    • 51
  • Limerick, Ireland
    • 20
• Italy
  • Bergamo, Italy
    • 80
  • Genova, Italy
    • 38
  • Genova, Italy
    • 88
  • Magenta, Italy
    • 79
  • Napoli, Italy
    • 98
  • Prato, Italy
    • 67
  • Roma, Italy
    • 36
  • Verona, Italy
    • 39
• Mexico
  • Chihuahua, Mexico
    • 194
  • Chihuahua, Mexico
    • 195
  • Guadalajara, Mexico
    • 193
  • Monterrey, Mexico
    • 192
  • San Luis Potosi, Mexico
    • 191
• Monaco
  • Monaco, Monaco
    • 60
• Poland
  • Bydgoszcz, Poland
    • 107
  • Poznan, Poland
    • 106
  • Warszawa, Poland
    • 113
  • Warszawa, Poland
    • 115
  • Wroclaw, Poland
    • 108
• Portugal
  • Coimbra, Portugal
    • 69
  • Lisboa, Portugal
    • 76
  • Lisbon, Portugal
    • 27
  • Ponte De Lima, Portugal
    • 14
  • Porto, Portugal
    • 81
• Romania
  • Bacau, Romania
    • 54
  • Braila, Romania
    • 74
  • Bucharest, Romania
    • 25
  • Bucharest, Romania
    • 24
  • Bucharest, Romania
    • 28
  • Bucharest, Romania
    • 32
  • Bucharest, Romania
    • 57
  • Cluj-Napoca, Romania
    • 12
  • Galati, Romania
    • 96
  • Iasi, Romania
    • 26
• Spain
  • A Coruna, Spain
    • 16
  • A Coruna, Spain
    • 52
  • Madrid, Spain
    • 30
  • Madrid, Spain
    • 83
  • Sabadell, Spain
    • 82
  • Vigo, Spain
    • 65
• Switzerland
  • St. Gallen, Switzerland
    • 53
  • Zürich, Switzerland
    • 50
• United Kingdom
  • Ashford, United Kingdom
    • 86
  • Brighton, United Kingdom
    • 78
  • Leeds, United Kingdom
    • 59
  • London, United Kingdom
    • 19
  • Poole, United Kingdom
    • 77
  • Sheffield, United Kingdom
    • 55
  • Upton, United Kingdom
    • 73
  • Wigan, United Kingdom
    • 99
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • 141
    • Tuscaloosa, Alabama, United States
      • 214
  • Arizona
    • Tucson, Arizona, United States
      • 159
  • Arkansas
    • Hot Springs, Arkansas, United States
      • 152
  • California
    • Covina, California, United States
      • 147
    • Fullerton, California, United States
      • 161
    • La Mesa, California, United States
      • 217
    • Los Angeles, California, United States
      • 149
    • Menifee, California, United States
      • 144
    • Roseville, California, United States
      • 185
    • Sacramento, California, United States
      • 208
    • Van Nuys, California, United States
      • 189
    • Whittier, California, United States
      • 148
  • Delaware
    • Lewes, Delaware, United States
      • 220
  • Florida
    • Aventura, Florida, United States
      • 142
    • Fort Lauderdale, Florida, United States
      • 216
    • Gainesville, Florida, United States
      • 162
    • Vero Beach, Florida, United States
      • 209
  • Idaho
    • Coeur d'Alene, Idaho, United States
      • 145
  • Illinois
    • Maywood, Illinois, United States
      • 202
  • Kentucky
    • Lexington, Kentucky, United States
      • 134
  • Maryland
    • Baltimore, Maryland, United States
      • 178
  • Michigan
    • Battle Creek, Michigan, United States
      • 137
    • Detroit, Michigan, United States
      • 153
    • Lansing, Michigan, United States
      • 155
  • Minnesota
    • Eagan, Minnesota, United States
      • 204
    • Rochester, Minnesota, United States
      • 180
    • Saint Louis Park, Minnesota, United States
      • 143
  • Nebraska
    • Omaha, Nebraska, United States
      • 135
  • Nevada
    • Reno, Nevada, United States
      • 170
  • New Jersey
    • Teaneck, New Jersey, United States
      • 201
    • Voorhees, New Jersey, United States
      • 150
  • New Mexico
    • Albuquerque, New Mexico, United States
      • 205
  • New York
    • Albany, New York, United States
      • 154
    • Brooklyn, New York, United States
      • 136
    • Orchard Park, New York, United States
      • 219
    • Plainview, New York, United States
      • 207
    • Syracuse, New York, United States
      • 167
  • Ohio
    • Cincinnati, Ohio, United States
      • 140
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • 184
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States
      • 164
    • Duncansville, Pennsylvania, United States
      • 132
    • Wyomissing, Pennsylvania, United States
      • 190
  • South Carolina
    • Charleston, South Carolina, United States
      • 210
    • Myrtle Beach, South Carolina, United States
      • 187
    • Orangeburg, South Carolina, United States
      • 203
  • Tennessee
    • Jackson, Tennessee, United States
      • 133
    • Knoxville, Tennessee, United States
      • 160
  • Texas
    • Austin, Texas, United States
      • 138
    • Corpus Christi, Texas, United States
      • 151
    • Dallas, Texas, United States
      • 131
    • Dallas, Texas, United States
      • 146
    • Dallas, Texas, United States
      • 213
    • Houston, Texas, United States
      • 166
    • Houston, Texas, United States
      • 212
    • San Antonio, Texas, United States
      • 139
    • Sugar Land, Texas, United States
      • 181
    • Victoria, Texas, United States
      • 165
  • Virginia
    • Arlington, Virginia, United States
      • 211
  • Washington
    • Spokane, Washington, United States
      • 157
  • West Virginia
    • Clarksburg, West Virginia, United States
      • 163
  • Wisconsin
    • Glendale, Wisconsin, United States
      • 215

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject must have a diagnosis of Rheumatoid Arthritis (RA) at Screening, as defined by the 2010 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aletaha D et al, 2010)
• Subject must have a positive Rheumatoid Factor (RF) and/or a positive anti-Cyclic Citrullinated Peptide antibody (anti-CCP) as determined by the central laboratory at Screening

• Subject must have moderate to severe RA disease at Screening and Baseline defined as:

  1. Screening (all criteria required)

     • ≥ 4 swollen joints (of 28 prespecified joints)
     • Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2
     • C-Reactive Protein (CRP) concentration ≥ 10 mg/L (or 1.0 mg/dL) or Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hr

  2. Baseline (both criteria required)

     • ≥ 4 swollen joints (of 28 prespecified joints)
     • Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2
• Subject must have inadequately responded previously to Methotrexate (MTX)
• Subject is using MTX 15 to 25 mg/week orally or subcutaneously at Screening and has used the same MTX regimen for a minimum of 28 days prior to Baseline

Exclusion Criteria:

• Subject has previously received any biological Disease Modifying Antirheumatic Drug (DMARD) or has received treatment with cyclophosphamide, chlorambucil, Janus Kinase, phosphodiesterase 4 inhibitors or investigational agents such as spleen tyrosine kinase
• Diagnosis of any other inflammatory arthritis
• Infected with Tuberculosis (TB) or high risk of acquiring TB infection
• Subjects with concurrent acute or chronic viral hepatitis B or C infection
• Subjects with a history of chronic or recurrent infections or subjects at high risk of infection
• Use of prohibited medications like nonbiological DMARDs (excluding MTX), biological DMARDs excluding study medications, experimental therapy, IA hyaluronic acid

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Certolizumab Pegol + Methotrexate (CZP + MTX)	Biological: Certolizumab Pegol (CZP); Active substance: an injectable volume of 1 ml solution for injection CZP; Pharmaceutical form: prefilled syringes CZP; Concentration: 200 mg/ml CZP; Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal.; Other Names: Cimzia; CZP; Drug: Methotrexate (MTX); Active substance: Methotrexate; Pharmaceutical form: oral tablet; Concentration: 15-25 mg/week; Route of Administration: MTX orally; Other Names: MTX
Active Comparator: Adalimumab + Methotrexate (ADA + MTX)	Drug: Methotrexate (MTX); Active substance: Methotrexate; Pharmaceutical form: oral tablet; Concentration: 15-25 mg/week; Route of Administration: MTX orally; Other Names: MTX; Biological: Adalimumab (ADA); Active substance: an injectable volume of 0.8 ml solution for injection ADA; Pharmaceutical form: prefilled syringes ADA; Concentration: 40 mg/0.8 ml ADA; Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal.; Other Names: Humira; ADA
Active Comparator: CZP + MTX followed by ADA + MTX; Those subjects who received Certolizumab Pegol (400 mg at Weeks 0, 2, 4 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) at Baseline and are Non-Responders at Week 12, switch to Adalimumab (40 mg) + Methotrexate (ADA + MTX) after Week 12.	Biological: Certolizumab Pegol (CZP); Active substance: an injectable volume of 1 ml solution for injection CZP; Pharmaceutical form: prefilled syringes CZP; Concentration: 200 mg/ml CZP; Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal.; Other Names: Cimzia; CZP; Drug: Methotrexate (MTX); Active substance: Methotrexate; Pharmaceutical form: oral tablet; Concentration: 15-25 mg/week; Route of Administration: MTX orally; Other Names: MTX; Biological: Adalimumab (ADA); Active substance: an injectable volume of 0.8 ml solution for injection ADA; Pharmaceutical form: prefilled syringes ADA; Concentration: 40 mg/0.8 ml ADA; Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal.; Other Names: Humira; ADA
Active Comparator: ADA + MTX followed by CZP + MTX; Those subjects who received Adalimumab (40 mg + Placebo at Weeks 0, 2, 4 followed by 40 mg ADA every two weeks) + Methotrexate (ADA+ MTX) at Baseline and are Non-Responders at Week 12, switch to Certolizumab Pegol (400 mg at Weeks 12, 14, 16 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) after Week 12.	Biological: Certolizumab Pegol (CZP); Active substance: an injectable volume of 1 ml solution for injection CZP; Pharmaceutical form: prefilled syringes CZP; Concentration: 200 mg/ml CZP; Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal.; Other Names: Cimzia; CZP; Drug: Methotrexate (MTX); Active substance: Methotrexate; Pharmaceutical form: oral tablet; Concentration: 15-25 mg/week; Route of Administration: MTX orally; Other Names: MTX; Biological: Adalimumab (ADA); Active substance: an injectable volume of 0.8 ml solution for injection ADA; Pharmaceutical form: prefilled syringes ADA; Concentration: 40 mg/0.8 ml ADA; Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal.; Other Names: Humira; ADA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12	Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).	Week 12
Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104	DAS28 [ESR] was 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 Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.	Week 104

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Week 12 Responders Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104	DAS28 [ESR] was 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 Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity. The definition of Week 12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline.	Week 104
Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 6	Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).	Week 6
Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 6	DAS28 [ESR] was 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 Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.	Week 6
Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12	DAS28 [ESR] was 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 Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.	Week 12
Percentage of Subjects With a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104, in Subjects Responding at Both Week 6 and Week 12	DAS28 [ESR] was 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 Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity. The definition of Week 6/12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline.	Week 104
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 104	HAQ-DI was derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), and the total HAQ-DI was scored on the scale of 0-3 as well. Change from Baseline was computed as the value at Week 104 minus the Baseline value. A negative value in Change from Baseline indicates an improvement.	From Baseline to Week 104
Kaplan-Meier Estimates of Proportion of Subjects Who Discontinued After Response at Week 12	Response at Week 12 means that a subject had either a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12 or had a reduction of DAS28 [ESR] ≥ 1.2 from Baseline to Week 12. Kaplan-Meier Estimates of Proportion of Subjects Discontinued are presented per study week (days relative to Week 12 visit).	From Week 12 up to Week 104

Collaborators and Investigators

• Sponsor: UCB Pharma SA
• Collaborators: Parexel

Publications and helpful links

General Publications

• Smolen JS, Burmester GR, Combe B, Curtis JR, Hall S, Haraoui B, van Vollenhoven R, Cioffi C, Ecoffet C, Gervitz L, Ionescu L, Peterson L, Fleischmann R. Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study. Lancet. 2016 Dec 3;388(10061):2763-2774. doi: 10.1016/S0140-6736(16)31651-8. Epub 2016 Nov 15. Erratum In: Lancet. 2017 Feb 4;389(10068):e2.
• Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1.

Helpful Links

• FDA Safety Alerts and Recalls
• Product Information

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: December 27, 2011
• First Posted (Estimate): December 28, 2011

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 4, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Cimzia; Certolizumab Pegol; Adalimumab; Humira
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Adalimumab; Methotrexate; Certolizumab Pegol
• Other Study ID Numbers: RA0077; 2011-002067-20 (EudraCT Number)