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

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ClinicalTrials.gov Identifier: NCT00960440
Recruitment Status : Completed
First Posted : August 17, 2009
Results First Posted : January 10, 2013
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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 
Other                1                1                1                0 



  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
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 
Overall Participants Analyzed 
[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

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6

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 ]
  Show Outcome Measure 17

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 ]
  Show Outcome Measure 20

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 ]
  Show Outcome Measure 22

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 ]
  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 ]
  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:   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 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 47


  Serious Adverse Events


  Other Adverse Events

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 (27.82%)   43/134 (32.09%)   46/132 (34.85%)   35/199 (17.59%)   30/200 (15.00%) 
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



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