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Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00413699
Recruitment Status : Completed
First Posted : December 20, 2006
Results First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Intervention: Drug: CP-690,550

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 414 sites globally.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants had previously participated in qualifying studies.

Reporting Groups
  Description
Tofacitinib 5 Milligrams (mg) Twice Daily (BID) Participants with non-zero average total daily dose across study <15 were assigned to 5 mg BID
Tofacitinib 10 mg BID Participants with average total daily dose across study >/=15 were assigned to 10 mg BID

Participant Flow:   Overall Study
    Tofacitinib 5 Milligrams (mg) Twice Daily (BID)   Tofacitinib 10 mg BID
STARTED   1123   3358 
COMPLETED   484   1653 
NOT COMPLETED   639   1705 
Death                25                30 
Lack of Efficacy                59                115 
Lost to Follow-up                31                101 
Protocol Violation                38                89 
Pregnancy                10                8 
Did not meet entrance criteria                2                2 
Medication error without adverse event                0                1 
Study terminated by Sponsor                0                1 
Not specified                67                211 
Adverse event related to study drug                178                527 
Adverse event not related to study drug                113                248 
Missing end of study page                0                4 
No longer willing to participate                116                368 



  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.
No text entered.

Reporting Groups
  Description
Tofacitinib 5 Milligrams (mg) Twice Daily (BID) Participants with non-zero average daily dose across study <15 were assigned to 5 mg BID
Tofacitinib 10 mg BID Participants with average total daily dose across study >/=15 were assigned to 10 mg BID
Total Total of all reporting groups

Baseline Measures
   Tofacitinib 5 Milligrams (mg) Twice Daily (BID)   Tofacitinib 10 mg BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 1123   3358   4481 
Age, Customized 
[Units: Participants]
     
<18 years   0   0   0 
18 to 64 years   916   2838   3754 
>=65 years   207   520   727 
Sex/Gender, Customized 
[Units: Number of participants]
     
Female   927   2744   3671 
Male   196   614   810 


  Outcome Measures

1.  Primary:   Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports   [ Time Frame: Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug ]

2.  Primary:   The Long-term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis   [ Time Frame: Includes AEs for every visit and up to 999 days after last dose of study drug ]

3.  Secondary:   Percent of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses   [ Time Frame: Every visit until study completion ]

4.  Secondary:   Area Under American College of Rheumatology (ACR) n Curve   [ Time Frame: Not applicable as no data were collected for this endpoint. ]

5.  Secondary:   Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR])   [ Time Frame: Every visit until study completion ]

6.  Secondary:   Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2   [ Time Frame: Every visit until study completion ]

7.  Secondary:   Health Assessment Questionnaire – Disability Index (HAQ-DI) Score   [ Time Frame: Every visit until study completion ]

8.  Secondary:   Short-Form-36 Health Survey (SF-36) Score   [ Time Frame: Every visit until study completion ]

9.  Secondary:   FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU)   [ Time Frame: Every visit until study completion ]

10.  Secondary:   Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study   [ Time Frame: Every 6 months until study completion ]

11.  Secondary:   Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Pneumococcal Vaccine as Defined by ≥ 2-fold Increase in Antibody Concentrations   [ Time Frame: From vaccine sub-study visit 2 (baseline) to sub-study visit 4 ]

12.  Secondary:   Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Seasonal Influenza Vaccine as Defined by ≥ 4-fold Increase in Antibody Titers   [ Time Frame: From vaccine sub-study visit 2 (baseline) to sub-study visit 4 ]

13.  Secondary:   Vaccine Sub-study. Percentage of Participants Achieving Protective Antibody Titers to the Seasonal Influenza Vaccine as Measured by a Hemagglutination Inhibition (HI) Assay Titer of ≥ 1:40 in ≥ 2 of 3 Influenza Antigens at Vaccine Sub-study Visit 3 and 4   [ Time Frame: From vaccine sub-study visit 2 (baseline) to sub-study visit 4 ]

14.  Secondary:   Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4   [ Time Frame: From vaccine sub-study visit 2 (baseline) to sub-study visit 4 ]

15.  Secondary:   Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 3 Influenza Antigens as Defined by ≥ 4-fold Increase in Antibody Titers From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4   [ Time Frame: From vaccine sub-study visit 2 (baseline) to sub-study visit 4 ]

16.  Secondary:   Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4   [ Time Frame: From vaccine sub-study visit 2 (baseline) to sub-study visit 4 ]

17.  Secondary:   Vaccine Sub-study. Fold Increase of Anti-influenza Antibody Levels to Each of the 3 Influenza Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4   [ Time Frame: From vaccine sub-study visit 2 (baseline) to sub-study visit 4 ]

18.  Secondary:   Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4   [ Time Frame: From vaccine sub-study visit 2 (baseline) to sub-study visit 4 ]

19.  Secondary:   Vaccine Sub-study. Titers of Anti-influenza Antibodies at Vaccine Sub-study Visit 3 and 4   [ Time Frame: From vaccine sub-study visit 2 (baseline) to sub-study visit 4 ]


  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

All information is based on protocol Amendment 25 with a database release date of 02 March 2017.

One serious adverse event in the Tofacitinib 5mg BID group could not be coded ("septic shock and pneumonia") and has not been included.



  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
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00413699     History of Changes
Other Study ID Numbers: A3921024
2006-005035-19 ( EudraCT Number )
First Submitted: December 18, 2006
First Posted: December 20, 2006
Results First Submitted: November 17, 2017
Results First Posted: March 27, 2018
Last Update Posted: March 27, 2018