Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (REALISTIC)

• ClinicalTrials.gov Identifier: NCT00717236
• Recruitment Status: Completed
• First Posted: July 17, 2008
• Results First Posted: May 6, 2011
• Last Update Posted: August 1, 2018
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

Brief Summary:

This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: Certolizumab pegol (CZP); Other: Placebo	Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:

The treatment period starts with a 12-week, double-blind, placebo-controlled, randomized period followed by an open-label extension phase. In the double-blind phase, eligible patients are randomized (4:1 ratio) to receive either certolizumab pegol (CZP) or Placebo up to and including Week 10. The randomization will be stratified according to the three factors: concomitant use of methotrexate (MTX, Yes or No), prior anti-tumor necrosis factor (anti-TNF) use (Yes or No), and disease duration categories (< 2 years or ≥ 2 years). From Week 12 all patients remaining in the study receive open-label CZP for a minimum 16 additional weeks until CZP is commercially available.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1648 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.
• Study Start Date: July 2008
• Actual Primary Completion Date: March 2010
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Certolizumab pegol (CZP)	Drug: Certolizumab pegol (CZP); 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.; Other Name: Cimzia
Placebo Comparator: Placebo	Other: Placebo; Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.

Outcome Measures

Primary Outcome Measures :

1. American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Baseline, Week 12 ]
   ACR20 responders are 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 (PhGADA-VAS)

Secondary Outcome Measures :

1. American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use. [ Time Frame: Baseline, Week 12 ]
   ACR20 responders are 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 (PhGADA-VAS)
2. American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use. [ Time Frame: Baseline, Week 12 ]
   ACR20 responders are 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 (PhGADA-VAS)
3. American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use [ Time Frame: Baseline, Week 12 ]
   ACR20 responders are 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 (PhGADA-VAS)
4. American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use [ Time Frame: Baseline, Week 12 ]
   ACR20 responders are 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 (PhGADA-VAS)
5. American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years [ Time Frame: Baseline, Week 12 ]
   ACR20 responders are 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 (PhGADA-VAS)
6. American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years. [ Time Frame: Baseline, Week 12 ]
   ACR20 responders are 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 (PhGADA-VAS)
7. American College of Rheumatology 50% (ACR50) Response at Week 12 [ Time Frame: Baseline, Week 12 ]
   ACR50 responders are subjects with at least 50% 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 (PhGADA-VAS)
8. American College of Rheumatology 70% (ACR70) Response at Week 12. [ Time Frame: Baseline, Week 12 ]
   ACR70 responders are subjects with at least 70% 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 (PhGADA-VAS)
9. Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12 [ Time Frame: Baseline, Week 12 ]
   DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
10. Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12 [ Time Frame: Baseline, Week 12 ]
    SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
11. Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12 [ Time Frame: Baseline, Week 12 ]
    CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
12. DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12 [ Time Frame: Week 12 ]
    DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity.
13. SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12 [ Time Frame: Week 12 ]
    SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.
14. CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12 [ Time Frame: Week 12 ]
    CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.
15. Change From Baseline in Tender Joint Count (TJC) at Week 12 [ Time Frame: Baseline, Week 12 ]
    TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
16. Change From Baseline in Swollen Joint Count (SJC) at Week 12 [ Time Frame: Baseline, Week 12 ]
    SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
17. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 [ Time Frame: Baseline, Week 12 ]
    HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
18. Change From Baseline in C-reactive Protein (CRP) at Week 12 [ Time Frame: Baseline, Week 12 ]
    Change from baseline in CRP (mg/L) is computed as the ratio of Week 12 value divided by baseline value. A ratio less then 1 indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
19. Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12 [ Time Frame: Baseline, Week 12 ]
    Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
20. Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12 [ Time Frame: Baseline, Week 12 ]
    Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
21. Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12 [ Time Frame: Baseline, Week 12 ]
    Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.
22. Time to Sustained American College of Rheumatology 20% (ACR20) Response [ Time Frame: Baseline up to Week 12 ]
    The time from randomization to sustained ACR20 response at 2 consecutive visits (at the latest on Week 12).
23. European League Against Rheumatism (EULAR) Response at Week 12 [ Time Frame: Baseline, Week 12 ]
    EULAR response (good response, moderate response, or no response) is defined based on the present value and improvement from baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive protein)].
24. American College of Rheumatology 20% (ACR20) Response at Week 28 [ Time Frame: Baseline, Week 28 ]
    ACR20 responders are 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 (PhGADA-VAS). This analysis was carried out using imputation.
25. American College of Rheumatology 50% (ACR50) Response at Week 28 [ Time Frame: Baseline, Week 28 ]
    ACR50 responders are subjects with at least 50% 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 (PhGADA-VAS). This analysis was carried out using imputation.
26. American College of Rheumatology 70% (ACR70) Response at Week 28 [ Time Frame: Baseline, Week 28 ]
    ACR70 responders are subjects with at least 70% 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 (PhGADA-VAS). This analysis was carried out using imputation.
27. Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28 [ Time Frame: Baseline, Week 28 ]
    DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
28. Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28 [ Time Frame: Baseline, Week 28 ]
    SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
29. Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28 [ Time Frame: Baseline, Week 28 ]
    CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
30. DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28 [ Time Frame: Week 28 ]
    DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. This analysis was carried out using imputation.
31. SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28 [ Time Frame: Week 28 ]
    SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.
32. CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28 [ Time Frame: Week 28 ]
    CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.
33. Change From Baseline in Tender Joint Count (TJC) at Week 28 [ Time Frame: Baseline, Week 28 ]
    TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
34. Change From Baseline in Swollen Joint Count (SJC) at Week 28 [ Time Frame: Baseline, Week 28 ]
    SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
35. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28 [ Time Frame: Baseline, Week 28 ]
    HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
36. Change From Baseline in C-reactive Protein (CRP) at Week 28 [ Time Frame: Baseline, Week 28 ]
    Change from Baseline in CRP (mg/L) is computed as the ratio of the value at Week 28 divided by Baseline value. A ratio less then 1 indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
37. Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28 [ Time Frame: Baseline, Week 28 ]
    Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
38. Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28 [ Time Frame: Baseline, Week 28 ]
    Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).
39. Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28 [ Time Frame: Baseline, Week 28 ]
    Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Adult patient with established moderate to severe rheumatoid arthritis

Exclusion Criteria:

• All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
• Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials

Contacts and Locations

Locations

United States, Alabama

Birmingham, Alabama, United States

Montgomery, Alabama, United States

United States, Arizona

Phoenix, Arizona, United States

Tucson, Arizona, United States

United States, Arkansas

Hot Springs, Arkansas, United States

Little Rock, Arkansas, United States

United States, California

Fullerton, California, United States

La Jolla, California, United States

Los Angeles, California, United States

Palm Desert, California, United States

Sacramento, California, United States

Santa Barbara, California, United States

Santa Maria, California, United States

Tustin, California, United States

Westlake Village, California, United States

Whittier, California, United States

United States, Colorado

Denver, Colorado, United States

United States, Connecticut

Danbury, Connecticut, United States

Trumbull, Connecticut, United States

United States, Delaware

Lewes, Delaware, United States

Newark, Delaware, United States

United States, District of Columbia

Washington, District of Columbia, United States

United States, Florida

Boca Raton, Florida, United States

Delray Beach, Florida, United States

Gainesville, Florida, United States

Jacksonville, Florida, United States

Orlando, Florida, United States

South Miami, Florida, United States

Tampa, Florida, United States

Tavares, Florida, United States

United States, Georgia

Atlanta, Georgia, United States

United States, Idaho

Coeur d'Alene, Idaho, United States

Idaho Falls, Idaho, United States

United States, Illinois

Maywood, Illinois, United States

Peoria, Illinois, United States

Rock Island, Illinois, United States

Springfield, Illinois, United States

United States, Indiana

Evansville, Indiana, United States

Indianapolis, Indiana, United States

United States, Kansas

Wichita, Kansas, United States

United States, Kentucky

Louisville, Kentucky, United States

United States, Louisiana

Covington, Louisiana, United States

Lake Charles, Louisiana, United States

United States, Maryland

Baltimore, Maryland, United States

Columbia, Maryland, United States

Frederick, Maryland, United States

Wheaton, Maryland, United States

United States, Massachusetts

Boston, Massachusetts, United States

Fall River, Massachusetts, United States

United States, Michigan

Battle Creek, Michigan, United States

Kalamazoo, Michigan, United States

Lansing, Michigan, United States

Petoskey, Michigan, United States

United States, Minnesota

Duluth, Minnesota, United States

Rochester, Minnesota, United States

United States, Missouri

Saint Louis, Missouri, United States

United States, New Jersey

New Brunswick, New Jersey, United States

Voorhees, New Jersey, United States

United States, New York

Albany, New York, United States

Bronx, New York, United States

New York, New York, United States

Orchard Park, New York, United States

Rochester, New York, United States

Roslyn, New York, United States

Smithtown, New York, United States

Syracuse, New York, United States

United States, North Carolina

Asheville, North Carolina, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Monroe, North Carolina, United States

Wilmington, North Carolina, United States

United States, Ohio

Columbus, Ohio, United States

Dayton, Ohio, United States

Fairfield, Ohio, United States

Mayfield, Ohio, United States

United States, Oklahoma

Oklahoma City, Oklahoma, United States

United States, Pennsylvania

Erie, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

West Reading, Pennsylvania, United States

Wexford, Pennsylvania, United States

United States, South Carolina

Charleston, South Carolina, United States

United States, Tennessee

Jackson, Tennessee, United States

United States, Texas

Amarillo, Texas, United States

Austin, Texas, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Lubbock, Texas, United States

San Antonio, Texas, United States

Sugar Land, Texas, United States

United States, Utah

Salt Lake City, Utah, United States

United States, Virginia

Newport News, Virginia, United States

Richmond, Virginia, United States

United States, Washington

Spokane, Washington, United States

Tacoma, Washington, United States

Yakima, Washington, United States

United States, West Virginia

Clarksburg, West Virginia, United States

United States, Wisconsin

Glendale, Wisconsin, United States

Milwaukee, Wisconsin, United States

Monroe, Wisconsin, United States

Canada, Alberta

Edmonton, Alberta, Canada

Canada, British Columbia

Vancouver, British Columbia, Canada

Canada, Manitoba

Winnipeg, Manitoba, Canada

Canada, Newfoundland and Labrador

St. John's, Newfoundland and Labrador, Canada

Canada, Nova Scotia

Halifax, Nova Scotia, Canada

Canada, Ontario

Hamilton, Ontario, Canada

Kitchener, Ontario, Canada

London, Ontario, Canada

Toronto, Ontario, Canada

Windsor, Ontario, Canada

Canada, Quebec

Montreal, Quebec, Canada

Rimouski, Quebec, Canada

Trois-Rivires, Quebec, Canada

Canada

Calgary, Canada

Mississauga, Canada

Newmarket, Canada

Sainte Foy, Canada

France

Amiens, France

Cahors, France

Corbeil Essonnes, France

Dreux, France

Lievin, France

Montpellier, France

Mulhouse, France

Nantes, France

Orleans, France

Paris, France

Pierre-Benite, France

Rennes, France

Saint Priest en Jarez, France

Germany

Bad Neuenahr, Germany

Baden, Germany

Berlin, Germany

Chemnitz, Germany

Dresden, Germany

Duisburg, Germany

Erfurt, Germany

Erlangen, Germany

Freiburg, Germany

Friedrichroda, Germany

Goslar, Germany

Hamburg, Germany

Hildesheim, Germany

Hoyerswerda, Germany

Jena, Germany

Kiel, Germany

Koln, Germany

Leipzig, Germany

Mainz, Germany

Munchen, Germany

Neuss, Germany

Osnabruck, Germany

Rostock, Germany

Wiesbaden, Germany

Zerbst, Germany

Italy

Bologna, Italy

Genova, Italy

Jesi, Italy

Modena, Italy

Palermo, Italy

Pisa, Italy

Prato, Italy

Siena, Italy

Udine, Italy

Netherlands

Apeldoorn, Netherlands

Arnhem, Netherlands

Den-Haag, Netherlands

Leiden, Netherlands

Spain

Barcelona, Spain

Coruna, Spain

La Laguna, Spain

Madrid, Spain

Murcia, Spain

Oviedo, Spain

Pontevedra, Spain

Sabadell, Spain

Salamanca, Spain

Santander, Spain

Santiago de Compostela, Spain

Torrelavega, Spain

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pope J, Bingham CO 3rd, Fleischmann RM, Dougados M, Massarotti EM, Wollenhaupt J, Duncan B, Coteur G, Weinblatt ME. Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity. Arthritis Res Ther. 2015 Nov 27;17:343. doi: 10.1186/s13075-015-0849-1.

Weinblatt ME, Fleischmann R, van Vollenhoven RF, Emery P, Huizinga TW, Cutolo M, van der Heijde D, Duncan B, Davies O, Luijtens K, Dougados M. Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population. Arthritis Res Ther. 2015 Nov 15;17:325. doi: 10.1186/s13075-015-0841-9.

Weinblatt ME, Fleischmann R, Huizinga TW, Emery P, Pope J, Massarotti EM, van Vollenhoven RF, Wollenhaupt J, Bingham CO 3rd, Duncan B, Goel N, Davies OR, Dougados M. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford). 2012 Dec;51(12):2204-14. doi: 10.1093/rheumatology/kes150. Epub 2012 Aug 25.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00717236
• Other Study ID Numbers: C87094; 2008-005427-28 ( EudraCT Number )
• First Posted: July 17, 2008
• Results First Posted: May 6, 2011
• Last Update Posted: August 1, 2018
• Last Verified: March 2012

Keywords provided by UCB Pharma:

Certolizumab pegol; Cimzia; Rheumatoid Arthritis; Joint Disease; Chronic Arthritis

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Certolizumab Pegol; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents