A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00814307

First received: December 22, 2008

Last updated: January 10, 2013

Last verified: January 2013

History of Changes

Results First Received: December 5, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Arthritis, Rheumatoid
Interventions:	Drug: CP-690,550 Drug: 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
CP-690,550 5 mg	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
CP-690,550 10 mg	CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg	Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg	Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

Participant Flow: Overall Study

	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg
STARTED	244	245	61	61
Treated	243	245	61	61
COMPLETED	232	218	54	51
NOT COMPLETED	12	27	7	10
Randomized but not treated	1	0	0	0
Adverse Event	3	9	3	2
Lack of Efficacy	1	1	3	4
Unspecified	1	2	0	1
Protocol Violation	2	8	1	1
Withdrawal by Subject	4	6	0	2
Death	0	1	0	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.
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Reporting Groups

	Description
CP-690,550 5 mg	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
CP-690,550 10 mg	CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg	Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg	Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Total	Total of all reporting groups

Baseline Measures

	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Total
Overall Participants Analyzed [Units: Participants]	243	245	61	61	610

Age [Units: Years] Mean (Standard Deviation)	52.2 (11.5)	52.4 (11.7)	50.7 (12.8)	48.8 (11.9)	51.8 (11.8)

Gender [Units: Participants]
Female	207	216	54	51	528
Male	36	29	7	10	82

Outcome Measures

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1. Primary:

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 [ Time Frame: Month 3 ]

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2. Primary:

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 [ Time Frame: Baseline, Month 3 ]

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3. Primary:

Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 [ Time Frame: Month 3 ]

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4. Secondary:

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 [ Time Frame: Week 2, Month 1, 2 ]

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5. Secondary:

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ]

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6. Secondary:

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 [ Time Frame: Week 2, Month 1, 2, 3 ]

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7. Secondary:

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ]

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8. Secondary:

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 [ Time Frame: Week 2, Month 1, 2, 3 ]

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9. Secondary:

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ]

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10. Secondary:

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

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11. Secondary:

Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 [ Time Frame: Month 6 ]

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12. Secondary:

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]

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13. Secondary:

Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ]

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14. Secondary:

Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]

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15. Secondary:

Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ]

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Measure Type	Secondary
Measure Title	Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6
Measure Description	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.
Time Frame	Month 4, 5, 6

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.
FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

Reporting Groups

	Description
CP-690,550 5 mg	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
CP-690,550 10 mg	CP-690,550 10 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 5 mg	Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
Placebo, Then CP-690,550 10 mg	Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.

Measured Values

	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg
Participants Analyzed [Units: Participants]	235	223	55	50
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 [Units: Units on a scale] Mean (Standard Deviation)
Month 4 (n= 235, 223, 55, 49)	0.97 (0.66)	0.88 (0.68)	1.08 (0.70)	1.09 (0.65)
Month 5 (n= 231, 221, 55, 50)	0.95 (0.69)	0.87 (0.69)	1.04 (0.59)	1.03 (0.64)
Month 6 (n= 229, 216, 54, 50)	0.94 (0.68)	0.86 (0.67)	1.05 (0.63)	1.00 (0.66)

No statistical analysis provided for Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6

16. Secondary:

Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]

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17. Secondary:

Patient Assessment of Arthritis Pain at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ]

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18. Secondary:

Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]

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19. Secondary:

Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ]

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20. Secondary:

Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 [ Time Frame: Baseline, Week 2, Month 1, 2, 3 ]

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21. Secondary:

Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ]

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22. Secondary:

36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 [ Time Frame: Baseline, Month 3 ]

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23. Secondary:

36-Item Short-Form Health Survey (SF-36) at Month 6 [ Time Frame: Month 6 ]

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24. Secondary:

Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

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25. Secondary:

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

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26. Secondary:

Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 [ Time Frame: Month 6 ]

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27. Secondary:

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 [ Time Frame: Month 6 ]

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28. Secondary:

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

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29. Secondary:

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 [ Time Frame: Month 6 ]

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30. Secondary:

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

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31. Secondary:

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6 [ Time Frame: Month 6 ]

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32. Secondary:

Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

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33. Secondary:

Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 [ Time Frame: Month 6 ]

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34. Secondary:

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

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35. Secondary:

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 [ Time Frame: Month 6 ]

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36. Secondary:

Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

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37. Secondary:

Number of Days as Assessed Using RA-HCRU at Month 6 [ Time Frame: Month 6 ]

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38. Secondary:

Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

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39. Secondary:

Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 [ Time Frame: Month 6 ]

Show Outcome Measure 39

40. Secondary:

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

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41. Secondary:

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 [ Time Frame: Month 6 ]

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42. Secondary:

Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ]

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43. Secondary:

Work Limitations Questionnaire (WLQ) Score at Month 6 [ Time Frame: Month 6 ]

Show Outcome Measure 43

44. Other Pre-specified:

Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain [ Time Frame: 2 weeks ]

Show Outcome Measure 44

45. Other Pre-specified:

Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis [ Time Frame: 2 weeks ]

Show Outcome Measure 45

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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):

Strand V, Kremer J, Wallenstein G, Kanik KS, Connell C, Gruben D, Zwillich SH, Fleischmann R. Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs. Arthritis Res Ther. 2015 Nov 4;17:307. doi: 10.1186/s13075-015-0825-9.

Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14. Erratum in: Ann Rheum Dis. 2017 Mar;76(3):611.

Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.

Fleischmann R, Kremer J, Cush J, Schulze-Koops H, Connell CA, Bradley JD, Gruben D, Wallenstein GV, Zwillich SH, Kanik KS; ORAL Solo Investigators. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012 Aug 9;367(6):495-507. doi: 10.1056/NEJMoa1109071.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00814307 History of Changes
Other Study ID Numbers:	A3921045
Study First Received:	December 22, 2008
Results First Received:	December 5, 2012
Last Updated:	January 10, 2013

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