Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors
![]() |
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: NCT00960440 |
Recruitment Status
:
Completed
First Posted
: August 17, 2009
Results First Posted
: January 10, 2013
Last Update Posted
: January 10, 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 |
---|---|
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 |
---|
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 |

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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

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 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 ] |
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 ] |
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 and 3 [ Time Frame: Week 2, Month 1, 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 and 6 ] |
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 ] |
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 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 ] |
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 ] |
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 ] |
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 ] |
14. Secondary: | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3 [ Time Frame: Week 2, Month 1, 3 ] |
15. Secondary: | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6 [ Time Frame: Month 4.5, 6 ] |
16. Secondary: | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 [ Time Frame: Baseline, Week 2, Month 1, 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 and 3 [ Time Frame: Baseline, Week 2, Month 1, 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 of Arthritis at Baseline, Week 2, Month 1 and 3 [ Time Frame: Baseline, Week 2, Month 1, 3 ] |
21. Secondary: | Physician Global Assessment of Arthritis at Month 4.5 and 6 [ Time Frame: Month 4.5, 6 ] |
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 ] |
23. Secondary: | 36-Item Short-Form Health Survey (SF-36) at Month 6 [ Time Frame: Month 6 ] |
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 ] |
25. Secondary: | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 [ Time Frame: Month 6 ] |
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 ] |
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 - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3 [ Time Frame: Baseline, Month 1, 3 ] |
31. Secondary: | Euro Quality of Life - 5 Dimensions (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, 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 Day as Assessed 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: | 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 ] |
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 ] |
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 ] |
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 ] |


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 |