Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00960440

First received: August 14, 2009

Last updated: December 6, 2012

Last verified: December 2012

History of Changes

Results First Received: December 6, 2012

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:	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
No text entered.

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	Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg	Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.

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	133	134	66	66
COMPLETED	107	103	53	48
NOT COMPLETED	26	31	13	18
Death	0	0	0	1
Adverse Event	12	12	4	4
Lack of Efficacy	2	5	3	8
Protocol Violation	2	8	3	4
Withdrawal by Subject	9	5	2	1
Unspecified	1	1	1	0

Baseline Characteristics

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Reporting Groups

	Description
CP-690,550 5 mg	CP-690,550 5 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	Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
Placebo, Then CP-690,550 10 mg	Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
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
Number of Participants [units: participants]	133	134	66	66	399
Age [units: years] Mean ± Standard Deviation	55.4 ± 11.5	55.1 ± 11.3	54.3 ± 11.7	54.5 ± 11.0	55.0 ± 11.3
Gender [units: participants]
Female	113	116	53	53	335
Male	20	18	13	13	64

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 ]

Show Outcome Measure 1

2. Primary:

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

Show Outcome Measure 2

3. Primary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

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 and 3 [ Time Frame: Week 2, Month 1, 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 and 6 ]

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

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 ]

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

11. Secondary:

Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6 [ Time Frame: Month 4.5, 6 ]

Show Outcome Measure 11

12. Secondary:

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

Show Outcome Measure 12

13. Secondary:

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

Show Outcome Measure 13

14. Secondary:

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

Show Outcome Measure 14

15. Secondary:

Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6 [ Time Frame: Month 4.5, 6 ]

Show Outcome Measure 15

16. Secondary:

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

Show Outcome Measure 16

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 and 3 [ Time Frame: Baseline, Week 2, Month 1, 3 ]

Show Outcome Measure 18

19. Secondary:

Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6 [ Time Frame: Month 4.5, 6 ]

Show Outcome Measure 19

20. Secondary:

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

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21. Secondary:

Physician Global Assessment of Arthritis at Month 4.5 and 6 [ Time Frame: Month 4.5, 6 ]

Show Outcome Measure 21

22. Secondary:

36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 [ Time Frame: Baseline, Week 2, Month 1, 3 ]

Hide Outcome Measure 22

Measure Type	Secondary
Measure Title	36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
Measure Description	SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time Frame	Baseline, Week 2, Month 1, 3
Safety Issue	No

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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups

	Description
CP-690,550 5 mg	CP-690,550 5 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	Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values

	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Number of Participants Analyzed [units: participants]	133	134	132
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 [units: units on a scale] Mean ± Standard Deviation
Baseline:Physical Functioning (n=133,134,132)	30.54 ± 10.76	31.61 ± 8.58	28.32 ± 9.30
Baseline:Role Physical (n=133,134,132)	33.66 ± 10.21	34.08 ± 9.67	32.53 ± 9.66
Baseline:Bodily Pain (n=133,134,132)	31.09 ± 8.13	32.55 ± 7.45	31.95 ± 7.70
Baseline:General Health (n=133,134,132)	35.84 ± 9.50	37.73 ± 9.18	34.82 ± 8.67
Baseline:Vitality (n=133,134,132)	39.71 ± 9.87	40.11 ± 10.26	38.41 ± 10.77
Baseline:Social Functioning (n=133,134,132)	37.40 ± 13.10	39.47 ± 12.11	35.95 ± 12.39
Baseline:Role Emotional (n=133,134,132)	37.58 ± 14.08	36.75 ± 13.58	35.52 ± 14.22
Baseline:Mental Health (n=133,134,132)	40.66 ± 11.63	41.91 ± 11.99	39.69 ± 12.66
Baseline:Physical Component Score(n=133,134,132)	30.72 ± 9.29	32.13 ± 7.58	29.98 ± 7.99
Baseline: Mental Component Score (n=133,134,132)	42.82 ± 12.69	43.24 ± 12.81	41.34 ± 13.25
Week 2:Physical Functioning (n=130,128,125)	33.28 ± 11.06	34.25 ± 9.30	30.25 ± 10.30
Week 2:Role Physical (n=130,128,125)	36.71 ± 10.23	38.45 ± 9.04	36.05 ± 10.48
Week 2:Bodily Pain (n=130,128,125)	37.01 ± 9.34	38.42 ± 7.70	33.77 ± 7.80
Week 2:General Health (n=130,128,125)	37.38 ± 8.52	38.57 ± 8.61	35.85 ± 8.76
Week 2:Vitality (n=130,128,125)	43.02 ± 10.18	43.89 ± 10.71	41.11 ± 10.62
Week 2:Social Functioning (n=130,128,125)	41.18 ± 12.79	42.29 ± 11.29	38.08 ± 12.18
Week 2:Role Emotional (n=130,128,125)	40.54 ± 12.94	40.62 ± 11.99	37.69 ± 13.49
Week 2:Mental Health (n=130,128,125)	43.72 ± 11.48	44.25 ± 11.19	42.07 ± 12.31
Week 2:Physical Component Score (n=130,128,125)	34.04 ± 9.51	35.69 ± 7.74	31.99 ± 8.58
Week 2:Mental Component Score (n=130,128,125)	45.77 ± 11.93	45.98 ± 11.95	43.57 ± 12.74
Month 1:Physical Functioning (n=124,123,123)	33.56 ± 11.14	35.64 ± 10.06	31.01 ± 10.15
Month 1: Role Physical (n=124,123,123)	38.25 ± 10.06	39.59 ± 9.98	36.33 ± 10.56
Month 1:Bodily Pain(n=124,123,123)	37.50 ± 9.45	40.02 ± 8.42	35.35 ± 8.77
Month 1:General Health (n=124,123,123)	38.09 ± 9.32	39.82 ± 9.25	36.64 ± 8.75
Month 1:Vitality (n=124,123,123)	44.33 ± 9.35	45.65 ± 11.47	41.85 ± 11.50
Month 1:Social Functioning (n=124,123,123)	40.96 ± 11.62	44.12 ± 11.65	39.00 ± 12.49
Month 1:Role Emotional (n=124,123,123)	41.05 ± 13.23	40.84 ± 12.86	38.87 ± 12.84
Month 1:Mental Health (n=124,123,123)	44.13 ± 11.68	46.18 ± 11.64	42.89 ± 11.92
Month 1:Physical Component Score (n=124,123,123)	34.88 ± 9.24	37.07 ± 8.40	32.72 ± 9.18
Month 1:Mental Component Score (n=124,123,123)	46.13 ± 11.94	47.28 ± 12.47	44.53 ± 12.42
Month 3:Physical Functioning (n=118,125,117)	34.78 ± 11.43	36.70 ± 10.56	30.54 ± 10.67
Month 3: Role Physical (n=118,125,117)	38.40 ± 10.49	40.19 ± 10.95	35.09 ± 10.66
Month 3:Bodily Pain (n=118,125,117)	39.25 ± 9.78	40.93 ± 9.67	34.26 ± 9.62
Month 3:General Health (n=118,125,117)	39.22 ± 9.78	40.21 ± 9.46	35.30 ± 9.30
Month 3:Vitality (n=118,125,117)	45.23 ± 10.89	46.23 ± 11.73	40.30 ± 11.71
Month 3:Social Functioning (n=118,125,117)	41.91 ± 12.37	44.49 ± 11.21	37.74 ± 12.12
Month 3:Role Emotional (n=118,125,116)	41.21 ± 12.57	41.84 ± 12.67	36.16 ± 14.50
Month 3:Mental Health (n=118,125,117)	44.58 ± 11.95	45.83 ± 11.59	40.89 ± 12.46
Month 3:Physical Component Score (n=118,125,116)	36.18 ± 9.96	38.01 ± 9.35	32.38 ± 9.35
Month 3:Mental Component Score (n=118,125,116)	46.40 ± 11.87	47.37 ± 12.01	41.91 ± 12.85

No statistical analysis provided for 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3

23. Secondary:

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

Show Outcome Measure 23

24. Secondary:

Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 [ Time Frame: Baseline, Week 2, Month 1, 3 ]

Show Outcome Measure 24

25. Secondary:

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

Show Outcome Measure 25

26. Secondary:

Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 [ Time Frame: Baseline, Week 2, Month 1, 3 ]

Hide Outcome Measure 26

Measure Type	Secondary
Measure Title	Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3
Measure Description	MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Number of participants with optimal sleep is reported.
Time Frame	Baseline, Week 2, Month 1, 3
Safety Issue	No

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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.

Reporting Groups

	Description
CP-690,550 5 mg	CP-690,550 5 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	Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.

Measured Values

	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Number of Participants Analyzed [units: participants]	133	134	132
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 [units: participants]
Baseline (n= 133, 134, 132)	53	59	48
Week 2 (n= 130, 128, 126)	52	62	50
Month 1 (n= 124, 123, 124)	59	58	53
Month 3 (n= 118, 125, 118)	53	56	47

No statistical analysis provided for Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3

27. Secondary:

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

Show Outcome Measure 27

28. Secondary:

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

Show Outcome Measure 28

29. Secondary:

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

Show Outcome Measure 29

30. Secondary:

Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3 [ Time Frame: Baseline, Month 1, 3 ]

Show Outcome Measure 30

31. Secondary:

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

Show Outcome Measure 31

32. Secondary:

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

Show Outcome Measure 32

33. Secondary:

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

Show Outcome Measure 33

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 ]

Show Outcome Measure 34

35. Secondary:

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

Show Outcome Measure 35

36. Secondary:

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

Show Outcome Measure 36

37. Secondary:

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

Show Outcome Measure 37

38. Secondary:

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

Show Outcome Measure 38

39. Secondary:

Number of Hours Per Day as Assessed 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 ]

Show Outcome Measure 40

41. Secondary:

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

Show Outcome Measure 41

42. Secondary:

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

Show Outcome Measure 42

43. Secondary:

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

Show Outcome Measure 43

44. Other Pre-specified:

Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 [ Time Frame: Week 2, Month 1, 3 ]

Show Outcome Measure 44

45. Other Pre-specified:

Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 [ Time Frame: Month 4.5, 6 ]

Show Outcome Measure 45

46. Other Pre-specified:

Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3 [ Time Frame: Month 3 ]

Show Outcome Measure 46

47. Other Pre-specified:

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Serious Adverse Events

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Other Adverse Events

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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.

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
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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

No publications provided by Pfizer

Publications automatically indexed to this study:

Burmester GR, Blanco R, Charles-Schoeman C, Wollenhaupt J, Zerbini C, Benda B, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Soma K, Bradley J, Mebus C; ORAL Step investigators. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet. 2013 Feb 9;381(9865):451-60. doi: 10.1016/S0140-6736(12)61424-X. Epub 2013 Jan 5.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00960440 History of Changes
Other Study ID Numbers:	A3921032
Study First Received:	August 14, 2009
Results First Received:	December 6, 2012
Last Updated:	December 6, 2012
Health Authority:	United States: Food and Drug Administration

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