A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00814307 |
Recruitment Status
:
Completed
First Posted
: December 24, 2008
Results First Posted
: January 11, 2013
Last Update Posted
: January 18, 2013
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type: | Interventional |
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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 |

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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No text entered. |
Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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No text entered. |
Reporting Groups
Description | |
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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 | |
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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 |
Other | 1 | 2 | 0 | 1 |
Protocol Violation | 2 | 8 | 1 | 1 |
Withdrawal by Subject | 4 | 6 | 0 | 2 |
Death | 0 | 1 | 0 | 0 |

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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No text entered. |
Reporting Groups
Description | |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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] |
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Female | 207 | 216 | 54 | 51 | 528 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Male | 36 | 29 | 7 | 10 | 82 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

1. Primary: | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 [ Time Frame: Month 3 ] |
2. Primary: | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 [ Time Frame: Baseline, Month 3 ] |
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 ] |
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 ] |
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 ] |
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 ] |
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 ] |
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 ] |
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 ] |
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 ] |
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 ] |
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 ] |
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 ] |
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 ] |
15. Secondary: | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ] |

Measure Type | Secondary |
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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. |
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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 | |
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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 | |
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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) |
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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 ] |
17. Secondary: | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ] |
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 ] |
19. Secondary: | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ] |
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 ] |
21. Secondary: | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 [ Time Frame: Month 4, 5, 6 ] |
22. Secondary: | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 [ Time Frame: Baseline, Month 3 ] |
23. Secondary: | 36-Item Short-Form Health Survey (SF-36) at Month 6 [ Time Frame: Month 6 ] |
24. Secondary: | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ] |
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 ] |
26. Secondary: | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 [ Time Frame: Month 6 ] |
27. Secondary: | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 [ Time Frame: Month 6 ] |
28. Secondary: | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ] |
29. Secondary: | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 [ Time Frame: Month 6 ] |
30. Secondary: | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ] |
31. Secondary: | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6 [ Time Frame: Month 6 ] |
32. Secondary: | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ] |
33. Secondary: | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 [ Time Frame: Month 6 ] |
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 ] |
35. Secondary: | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 [ Time Frame: Month 6 ] |
36. Secondary: | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ] |
37. Secondary: | Number of Days as Assessed Using RA-HCRU at Month 6 [ Time Frame: Month 6 ] |
38. Secondary: | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ] |
39. Secondary: | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 [ Time Frame: Month 6 ] |
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 ] |
41. Secondary: | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 [ Time Frame: Month 6 ] |
42. Secondary: | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 [ Time Frame: Baseline, Month 3 ] |
43. Secondary: | Work Limitations Questionnaire (WLQ) Score at Month 6 [ Time Frame: Month 6 ] |
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 ] |
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 ] |

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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No text entered. |

Certain Agreements:
Results Point of Contact:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
|
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
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):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00814307 History of Changes |
Other Study ID Numbers: |
A3921045 |
First Submitted: | December 22, 2008 |
First Posted: | December 24, 2008 |
Results First Submitted: | December 5, 2012 |
Results First Posted: | January 11, 2013 |
Last Update Posted: | January 18, 2013 |