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
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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	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 ]

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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 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 ]

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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 ]

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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 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 ]

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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 ]

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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 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 ]

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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 ]

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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 ]

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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 ]

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14. Secondary:

Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3 [ Time Frame: Week 2, Month 1, 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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16. Secondary:

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

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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 ]

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

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25. Secondary:

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

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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 ]

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

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31. Secondary:

Euro Quality of Life - 5 Dimensions (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, 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 Day as Assessed RA-HCRU at Month 6 [ Time Frame: Month 6 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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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