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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00717236
First received: July 15, 2008
Last updated: March 2, 2012
Last verified: March 2012
Results First Received: March 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Certolizumab pegol (CZP)
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study started in July 2008 with subjects from the United States, Canada, France, Germany, Italy, the Netherlands, and Spain. The primary completion date occurred in March 2010, with study completion in March 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 1648 subjects that were screened, 585 subjects had screen failures. Therefore, 1063 subjects were randomized in this study.

Reporting Groups
  Description
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.
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.

Participant Flow for 2 periods

Period 1:   Double-Blind Period
    Certolizumab Pegol (CZP)     Placebo  
STARTED     851     212  
COMPLETED     771     184  
NOT COMPLETED     80     28  
Adverse Event                 33                 6  
Lack of Efficacy                 6                 6  
Lost to Follow-up                 3                 5  
Withdrawal by Subject                 10                 2  
Loss of efficacy                 3                 0  
Other: Death                 1                 0  
Other: Pregnancy                 1                 0  
Other: Protocol Violation                 2                 0  
Other: Inclusion/Exclusion criteria                 6                 2  
Other: Site withdrew                 2                 0  
Other: Screening failure                 1                 0  
Other: subject withdrew consent                 1                 1  
Other: Abnormal chest X-ray                 2                 1  
Other: History of adenoid grown                 1                 0  
Other: History of cancer                 1                 0  
Other: Sponsor request                 1                 0  
Other: Inappropriate randomization                 1                 0  
Other: Detection of Hepatitis C Virus                 1                 0  
Other: Subject moved                 1                 1  
Other: Stopped taking DMARD                 1                 0  
Other: Prohibited medication taken                 2                 2  
Other: Transportation problems                 0                 1  
Other: Investigator Decision                 0                 1  

Period 2:   Open-Label Period
    Certolizumab Pegol (CZP)     Placebo  
STARTED     771     184  
COMPLETED     646     163  
NOT COMPLETED     125     21  
Adverse Event                 29                 4  
Lack of Efficacy                 30                 8  
Lost to Follow-up                 28                 4  
Withdrawal by Subject                 20                 2  
Loss of Efficacy                 6                 1  
Other: Peripheral Neuropathy                 0                 1  
Other: Lack of Compliance                 1                 1  
Other: History of Basal Cell Carcinoma                 1                 0  
Other: Moved                 1                 0  
Other: Investigator Decision                 1                 0  
Other: Loss of Staff (unblinded)                 1                 0  
Other: Sponsor Request                 3                 0  
Other: Cataract Surgery                 1                 0  
Other: Administration of Golimumab                 1                 0  
Other: Completion Accidently Performed                 1                 0  
Other: Medical Monitor Recommendation                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Certolizumab Pegol (CZP)     Placebo     Total  
Number of Participants  
[units: participants]
  851     212     1063  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     644     164     808  
>=65 years     207     48     255  
Age  
[units: years]
Mean ± Standard Deviation
  55.4  ± 12.43     53.9  ± 12.66     55.1  ± 12.49  
Gender  
[units: participants]
     
Female     660     169     829  
Male     191     43     234  
Region of Enrollment  
[units: participants]
     
France     14     0     14  
United States     575     141     716  
Canada     65     17     82  
Spain     26     8     34  
Netherlands     4     0     4  
Germany     154     44     198  
Italy     13     2     15  



  Outcome Measures
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1.  Primary:   American College of Rheumatology 20% (ACR20) Response at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use.   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use.   [ Time Frame: Baseline, Week 12 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:   American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years.   [ Time Frame: Baseline, Week 12 ]

8.  Secondary:   American College of Rheumatology 50% (ACR50) Response at Week 12   [ Time Frame: Baseline, Week 12 ]

9.  Secondary:   American College of Rheumatology 70% (ACR70) Response at Week 12.   [ Time Frame: Baseline, Week 12 ]

10.  Secondary:   Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12   [ Time Frame: Baseline, Week 12 ]

11.  Secondary:   Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12   [ Time Frame: Baseline, Week 12 ]

12.  Secondary:   Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12   [ Time Frame: Baseline, Week 12 ]

13.  Secondary:   DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12   [ Time Frame: Week 12 ]

14.  Secondary:   SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12   [ Time Frame: Week 12 ]

15.  Secondary:   CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12   [ Time Frame: Week 12 ]

16.  Secondary:   Change From Baseline in Tender Joint Count (TJC) at Week 12   [ Time Frame: Baseline, Week 12 ]

17.  Secondary:   Change From Baseline in Swollen Joint Count (SJC) at Week 12   [ Time Frame: Baseline, Week 12 ]

18.  Secondary:   Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12   [ Time Frame: Baseline, Week 12 ]

19.  Secondary:   Change From Baseline in C-reactive Protein (CRP) at Week 12   [ Time Frame: Baseline, Week 12 ]

20.  Secondary:   Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12   [ Time Frame: Baseline, Week 12 ]

21.  Secondary:   Change From Baseline in Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12   [ Time Frame: Baseline, Week 12 ]

22.  Secondary:   Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12   [ Time Frame: Baseline, Week 12 ]

23.  Secondary:   Time to Sustained American College of Rheumatology 20% (ACR20) Response   [ Time Frame: Baseline up to Week 12 ]

24.  Secondary:   European League Against Rheumatism (EULAR) Response at Week 12   [ Time Frame: Baseline, Week 12 ]

25.  Secondary:   American College of Rheumatology 20% (ACR20) Response at Week 28   [ Time Frame: Baseline, Week 28 ]

26.  Secondary:   American College of Rheumatology 50% (ACR50) Response at Week 28   [ Time Frame: Baseline, Week 28 ]

27.  Secondary:   American College of Rheumatology 70% (ACR70) Response at Week 28   [ Time Frame: Baseline, Week 28 ]

28.  Secondary:   Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28   [ Time Frame: Baseline, Week 28 ]

29.  Secondary:   Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28   [ Time Frame: Baseline, Week 28 ]

30.  Secondary:   Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28   [ Time Frame: Baseline, Week 28 ]

31.  Secondary:   DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28   [ Time Frame: Week 28 ]

32.  Secondary:   SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28   [ Time Frame: Week 28 ]

33.  Secondary:   CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28   [ Time Frame: Week 28 ]

34.  Secondary:   Change From Baseline in Tender Joint Count (TJC) at Week 28   [ Time Frame: Baseline, Week 28 ]

35.  Secondary:   Change From Baseline in Swollen Joint Count (SJC) at Week 28   [ Time Frame: Baseline, Week 28 ]

36.  Secondary:   Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28   [ Time Frame: Baseline, Week 28 ]

37.  Secondary:   Change From Baseline in C-reactive Protein (CRP) at Week 28   [ Time Frame: Baseline, Week 28 ]

38.  Secondary:   Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28   [ Time Frame: Baseline, Week 28 ]

39.  Secondary:   Change From Baseline in Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28   [ Time Frame: Baseline, Week 28 ]

40.  Secondary:   Change From Baseline in Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28   [ Time Frame: Baseline, Week 28 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
phone: +1 887 822 9493


No publications provided by UCB, Inc.

Publications automatically indexed to this study:

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00717236     History of Changes
Other Study ID Numbers: C87094, 2008-005427-28
Study First Received: July 15, 2008
Results First Received: March 10, 2011
Last Updated: March 2, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Spain: Spanish Agency of Medicines