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Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study (OPAL BROADEN)

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ClinicalTrials.gov Identifier: NCT01877668
Recruitment Status : Completed
First Posted : June 14, 2013
Results First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriatic Arthritis
Interventions: Drug: Tofacitinib 5 mg BID
Drug: Tofacitinib 10 mg BID
Drug: Adalimumab
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 611 participants screened for entry into the study, 422 received treatment.

Reporting Groups
  Description
Tofacitinib, 5 mg, Twice Daily Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Tofacitinib, 10 mg, Twice Daily Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Adalimumab, 40 mg, Every 2 Weeks Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Placebo/Tofacitinib, 5 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Placebo/Tofacitinib, 10 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.

Participant Flow:   Overall Study
    Tofacitinib, 5 mg, Twice Daily   Tofacitinib, 10 mg, Twice Daily   Adalimumab, 40 mg, Every 2 Weeks   Placebo/Tofacitinib, 5 mg, Twice Daily   Placebo/Tofacitinib, 10 mg, Twice Daily
STARTED   107 [1]   104 [1]   106 [1]   52 [1]   53 [1] 
COMPLETED   96   96   94   44   43 
NOT COMPLETED   11   8   12   8   10 
Death                0                0                0                1                0 
No longer met study criteria                1                0                1                0                0 
Insufficient clinical response                0                1                2                2                0 
Lost to Follow-up                0                2                1                0                0 
Withdrawal by Subject                2                0                3                2                2 
Not specified                1                1                1                1                3 
Protocol Violation                1                1                0                0                3 
Adverse event related to study drug                2                2                2                2                1 
Adverse event unrelated to study drug                4                1                2                0                1 
[1] Received treatment



  Baseline Characteristics

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.
All participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Tofacitinib, 5 mg, Twice Daily Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.
Tofacitinib, 10 mg, Twice Daily Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Adalimumab, 40 mg, Every 2 Weeks Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.
Placebo/Tofacitinib, 5 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.
Placebo/Tofacitinib, 10 mg, Twice Daily Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.
Total Total of all reporting groups

Baseline Measures
   Tofacitinib, 5 mg, Twice Daily   Tofacitinib, 10 mg, Twice Daily   Adalimumab, 40 mg, Every 2 Weeks   Placebo/Tofacitinib, 5 mg, Twice Daily   Placebo/Tofacitinib, 10 mg, Twice Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 107   104   106   52   53   422 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.4  (12.6)   46.9  (12.4)   47.4  (11.3)   46.1  (10.4)   49.3  (13.8)   47.9  (12.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      57  53.3%      62  59.6%      50  47.2%      28  53.8%      28  52.8%      225  53.3% 
Male      50  46.7%      42  40.4%      56  52.8%      24  46.2%      25  47.2%      197  46.7% 


  Outcome Measures

1.  Primary:   Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3   [ Time Frame: At end of Month 3 ]

2.  Primary:   Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score   [ Time Frame: From Baseline to Month 3 ]

3.  Secondary:   Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis   [ Time Frame: From Baseline to Month 12 ]

4.  Secondary:   Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12   [ Time Frame: At Month 12 ]

5.  Secondary:   Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12   [ Time Frame: At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 ]

6.  Secondary:   Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12   [ Time Frame: At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 ]

7.  Secondary:   Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12   [ Time Frame: At Week 2 and Months 1, 2, 4, 6, 9, and 12 ]

8.  Secondary:   Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score   [ Time Frame: From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12 ]

9.  Secondary:   Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels   [ Time Frame: From Baseline to end of Month 3 ]

10.  Secondary:   Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain   [ Time Frame: From Baseline to end of Month 3 ]

11.  Secondary:   Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis   [ Time Frame: From Baseline to end of Month 3 ]

12.  Secondary:   Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis   [ Time Frame: From Baseline to end of Month 3 ]

13.  Secondary:   Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count   [ Time Frame: From Baseline to end of Month 3 ]

14.  Secondary:   Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count   [ Time Frame: From Baseline to end of Month 3 ]

15.  Secondary:   Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12   [ Time Frame: At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 ]

16.  Secondary:   Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

17.  Secondary:   Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12   [ Time Frame: At Months 1, 3, 6, 9, and 12 ]

18.  Secondary:   Change From Baseline in Dactylitis Severity Score (DSS)   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

19.  Secondary:   Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

20.  Secondary:   Change From Baseline in the Leeds Enthesitis Index (LEI)   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

21.  Secondary:   Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

22.  Secondary:   Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

23.  Secondary:   Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

24.  Secondary:   Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

25.  Secondary:   Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

26.  Secondary:   Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

27.  Secondary:   Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

28.  Secondary:   Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

29.  Secondary:   Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

30.  Secondary:   Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

31.  Secondary:   Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

32.  Secondary:   Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

33.  Secondary:   Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

34.  Secondary:   Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

35.  Secondary:   Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

36.  Secondary:   Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

37.  Secondary:   Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

38.  Secondary:   Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

39.  Secondary:   Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]

40.  Secondary:   Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)   [ Time Frame: From Baseline to Months 1, 3, 6, 9, and 12 ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021


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

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01877668     History of Changes
Other Study ID Numbers: A3921091
2011-003668-55 ( EudraCT Number )
First Submitted: June 12, 2013
First Posted: June 14, 2013
Results First Submitted: December 4, 2016
Results First Posted: July 6, 2017
Last Update Posted: July 6, 2017