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 ]

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 ]

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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 ]

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 ]

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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 ]

Show Outcome Measure 24

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 ]

Show Outcome Measure 26

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 ]

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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 ]

Show Outcome Measure 35

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 ]

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:

Show Outcome Measure 47

Serious Adverse Events

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Time Frame	No text entered.
Additional Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Reporting Groups

	Description
CP-690,550 5 mg Up to Month 3	CP-690,550 5 mg tablet orally twice daily up to Month 3.
CP-690,550 10 mg Up to Month 3	CP-690,550 10 mg tablets orally twice daily up to Month 3.
Placebo Up to Month 3	Placebo matching to CP-690,550 5 mg tablet orally twice daily up to Month 3.
CP-690,550 5 mg From Month 3 to 6	CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
CP-690,550 10 mg From Month 3 to 6	CP-690,550 10 mg tablets orally twice daily from Month 3 to Month 6.

Serious Adverse Events

	CP-690,550 5 mg Up to Month 3	CP-690,550 10 mg Up to Month 3	Placebo Up to Month 3	CP-690,550 5 mg From Month 3 to 6	CP-690,550 10 mg From Month 3 to 6
Total, serious adverse events
# participants affected / at risk	2/133 (1.50%)	2/134 (1.49%)	6/132 (4.55%)	8/199 (4.02%)	8/200 (4.00%)
Blood and lymphatic system disorders
Anaemia ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	0/199 (0.00%)	2/200 (1.00%)
Cardiac disorders
Pericarditis ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	0/199 (0.00%)	1/200 (0.50%)
Eye disorders
Ulcerative keratitis ^{* 1}
# participants affected / at risk	0/133 (0.00%)	1/134 (0.75%)	0/132 (0.00%)	0/199 (0.00%)	0/200 (0.00%)
Gastrointestinal disorders
Nausea ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	0/199 (0.00%)	1/200 (0.50%)
Pancreatitis ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	1/199 (0.50%)	0/200 (0.00%)
Vomiting ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	0/199 (0.00%)	1/200 (0.50%)
General disorders
Drug ineffective ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	1/132 (0.76%)	0/199 (0.00%)	0/200 (0.00%)
Hepatobiliary disorders
Cholelithiasis ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	0/199 (0.00%)	1/200 (0.50%)
Infections and infestations
Bronchopneumonia ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	1/199 (0.50%)	0/200 (0.00%)
Diverticulitis ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	0/199 (0.00%)	1/200 (0.50%)
Gastroenteritis ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	1/132 (0.76%)	0/199 (0.00%)	0/200 (0.00%)
Pyelonephritis ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	0/199 (0.00%)	1/200 (0.50%)
Injury, poisoning and procedural complications
Contusion ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	1/132 (0.76%)	0/199 (0.00%)	0/200 (0.00%)
Foot fracture ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	1/132 (0.76%)	0/199 (0.00%)	0/200 (0.00%)
Joint sprain ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	1/132 (0.76%)	0/199 (0.00%)	0/200 (0.00%)
Metabolism and nutrition disorders
Dehydration ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	1/132 (0.76%)	0/199 (0.00%)	0/200 (0.00%)
Hyponatraemia ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	1/132 (0.76%)	0/199 (0.00%)	0/200 (0.00%)
Musculoskeletal and connective tissue disorders
Back pain ^{* 1}
# participants affected / at risk	1/133 (0.75%)	0/134 (0.00%)	0/132 (0.00%)	0/199 (0.00%)	0/200 (0.00%)
Nervous system disorders
Cerebrovascular accident ^{* 1}
# participants affected / at risk	1/133 (0.75%)	0/134 (0.00%)	0/132 (0.00%)	2/199 (1.01%)	0/200 (0.00%)
Transient ischaemic attack ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	1/199 (0.50%)	0/200 (0.00%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	1/132 (0.76%)	0/199 (0.00%)	0/200 (0.00%)
Pregnancy ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	1/132 (0.76%)	0/199 (0.00%)	0/200 (0.00%)
Psychiatric disorders
Mental disorder ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	1/199 (0.50%)	0/200 (0.00%)
Renal and urinary disorders
Goodpasture’s syndrome ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	1/132 (0.76%)	0/199 (0.00%)	0/200 (0.00%)
Renal failure acute ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	0/199 (0.00%)	1/200 (0.50%)
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	0/199 (0.00%)	1/200 (0.50%)
Pneumonia aspiration ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	1/199 (0.50%)	0/200 (0.00%)
Pulmonary embolism ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	0/199 (0.00%)	2/200 (1.00%)
Skin and subcutaneous tissue disorders
Panniculitis ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	1/199 (0.50%)	0/200 (0.00%)
Vascular disorders
Aortic aneurysm ^{* 1}
# participants affected / at risk	0/133 (0.00%)	1/134 (0.75%)	0/132 (0.00%)	0/199 (0.00%)	0/200 (0.00%)
Hypertension ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	1/199 (0.50%)	0/200 (0.00%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA 13.1

Other Adverse Events

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Time Frame	No text entered.
Additional Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Frequency Threshold

Threshold above which other adverse events are reported	2%

Reporting Groups

	Description
CP-690,550 5 mg Up to Month 3	CP-690,550 5 mg tablet orally twice daily up to Month 3.
CP-690,550 10 mg Up to Month 3	CP-690,550 10 mg tablets orally twice daily up to Month 3.
Placebo Up to Month 3	Placebo matching to CP-690,550 5 mg tablet orally twice daily up to Month 3.
CP-690,550 5 mg From Month 3 to 6	CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
CP-690,550 10 mg From Month 3 to 6	CP-690,550 10 mg tablets orally twice daily from Month 3 to Month 6.

Other Adverse Events

	CP-690,550 5 mg Up to Month 3	CP-690,550 10 mg Up to Month 3	Placebo Up to Month 3	CP-690,550 5 mg From Month 3 to 6	CP-690,550 10 mg From Month 3 to 6
Total, other (not including serious) adverse events
# participants affected / at risk	37/133	43/134	46/132	35/199	30/200
Gastrointestinal disorders
Abdominal pain upper ^{* 1}
# participants affected / at risk	3/133 (2.26%)	1/134 (0.75%)	0/132 (0.00%)	0/199 (0.00%)	0/200 (0.00%)
Constipation ^{* 1}
# participants affected / at risk	4/133 (3.01%)	3/134 (2.24%)	1/132 (0.76%)	0/199 (0.00%)	0/200 (0.00%)
Diarrhoea ^{* 1}
# participants affected / at risk	8/133 (6.02%)	5/134 (3.73%)	5/132 (3.79%)	0/199 (0.00%)	0/200 (0.00%)
Mouth ulceration ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	4/199 (2.01%)	0/200 (0.00%)
Nausea ^{* 1}
# participants affected / at risk	4/133 (3.01%)	2/134 (1.49%)	9/132 (6.82%)	4/199 (2.01%)	1/200 (0.50%)
General disorders
Fatigue ^{* 1}
# participants affected / at risk	1/133 (0.75%)	3/134 (2.24%)	0/132 (0.00%)	0/199 (0.00%)	0/200 (0.00%)
Oedema peripheral ^{* 1}
# participants affected / at risk	3/133 (2.26%)	1/134 (0.75%)	5/132 (3.79%)	0/199 (0.00%)	0/200 (0.00%)
Infections and infestations
Bronchitis ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	0/132 (0.00%)	6/199 (3.02%)	3/200 (1.50%)
Nasopharyngitis ^{* 1}
# participants affected / at risk	5/133 (3.76%)	6/134 (4.48%)	4/132 (3.03%)	6/199 (3.02%)	5/200 (2.50%)
Sinusitis ^{* 1}
# participants affected / at risk	1/133 (0.75%)	1/134 (0.75%)	4/132 (3.03%)	1/199 (0.50%)	4/200 (2.00%)
Upper respiratory tract infection ^{* 1}
# participants affected / at risk	5/133 (3.76%)	2/134 (1.49%)	4/132 (3.03%)	5/199 (2.51%)	8/200 (4.00%)
Urinary tract infection ^{* 1}
# participants affected / at risk	5/133 (3.76%)	3/134 (2.24%)	3/132 (2.27%)	4/199 (2.01%)	2/200 (1.00%)
Injury, poisoning and procedural complications
Muscle strain ^{* 1}
# participants affected / at risk	0/133 (0.00%)	3/134 (2.24%)	0/132 (0.00%)	0/199 (0.00%)	0/200 (0.00%)
Investigations
Blood creatine phosphokinase increased ^{* 1}
# participants affected / at risk	0/133 (0.00%)	3/134 (2.24%)	0/132 (0.00%)	0/199 (0.00%)	0/200 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^{* 1}
# participants affected / at risk	1/133 (0.75%)	1/134 (0.75%)	5/132 (3.79%)	0/199 (0.00%)	0/200 (0.00%)
Back pain ^{* 1}
# participants affected / at risk	2/133 (1.50%)	3/134 (2.24%)	2/132 (1.52%)	2/199 (1.01%)	4/200 (2.00%)
Muscle spasms ^{* 1}
# participants affected / at risk	0/133 (0.00%)	1/134 (0.75%)	3/132 (2.27%)	0/199 (0.00%)	0/200 (0.00%)
Rheumatoid arthritis ^{* 1}
# participants affected / at risk	3/133 (2.26%)	1/134 (0.75%)	4/132 (3.03%)	7/199 (3.52%)	0/200 (0.00%)
Nervous system disorders
Headache ^{* 1}
# participants affected / at risk	3/133 (2.26%)	8/134 (5.97%)	1/132 (0.76%)	1/199 (0.50%)	4/200 (2.00%)
Paraesthesia ^{* 1}
# participants affected / at risk	0/133 (0.00%)	1/134 (0.75%)	3/132 (2.27%)	0/199 (0.00%)	0/200 (0.00%)
Psychiatric disorders
Depression ^{* 1}
# participants affected / at risk	2/133 (1.50%)	4/134 (2.99%)	1/132 (0.76%)	0/199 (0.00%)	0/200 (0.00%)
Renal and urinary disorders
Haematuria ^{* 1}
# participants affected / at risk	0/133 (0.00%)	0/134 (0.00%)	3/132 (2.27%)	0/199 (0.00%)	0/200 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^{* 1}
# participants affected / at risk	3/133 (2.26%)	0/134 (0.00%)	5/132 (3.79%)	0/199 (0.00%)	0/200 (0.00%)
Skin and subcutaneous tissue disorders
Skin lesion ^{* 1}
# participants affected / at risk	1/133 (0.75%)	3/134 (2.24%)	0/132 (0.00%)	0/199 (0.00%)	0/200 (0.00%)
Vascular disorders
Hypertension ^{* 1}
# participants affected / at risk	1/133 (0.75%)	3/134 (2.24%)	1/132 (0.76%)	4/199 (2.01%)	2/200 (1.00%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA 13.1

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
No text entered.

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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