Trial Outcomes & Findings for Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550 (NCT NCT00414661)
NCT ID: NCT00414661
Last Updated: 2013-01-01
Results Overview
Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with LPD by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.
Recruitment status
COMPLETED
Target enrollment
162 participants
Primary outcome timeframe
Up to Month 24
Results posted on
2013-01-01
Participant Flow
Participants who received at least 1 dose of CP-690,550, placebo or adalimumab for the treatment of Rheumatoid Arthritis (RA) in previous studies and had ceased participation in other Phase 2B or 3 randomized, controlled or open-label study of CP-690,550 were eligible for this study.
Participant milestones
| Measure |
CP-690,550 >=10 mg
Participants who had received 1 dose CP-690,550 greater than or equal to (\>=) 10 milligram (mg) orally twice daily in any of the previous studies.
|
CP-690,550 <10 mg
Participants who had received 1 dose CP-690,550 less than (\<) 10 mg orally twice daily in any of the previous studies.
|
Placebo
Participants who had received 1 dose of matching-placebo in any of the previous studies.
|
Adalimumab
Participants who had received 1 dose of adalimumab in any of the previous studies.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
89
|
22
|
3
|
|
Overall Study
COMPLETED
|
34
|
75
|
20
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
14
|
2
|
3
|
Reasons for withdrawal
| Measure |
CP-690,550 >=10 mg
Participants who had received 1 dose CP-690,550 greater than or equal to (\>=) 10 milligram (mg) orally twice daily in any of the previous studies.
|
CP-690,550 <10 mg
Participants who had received 1 dose CP-690,550 less than (\<) 10 mg orally twice daily in any of the previous studies.
|
Placebo
Participants who had received 1 dose of matching-placebo in any of the previous studies.
|
Adalimumab
Participants who had received 1 dose of adalimumab in any of the previous studies.
|
|---|---|---|---|---|
|
Overall Study
Death
|
2
|
5
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
2
|
2
|
|
Overall Study
Other
|
6
|
3
|
0
|
0
|
Baseline Characteristics
Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550
Baseline characteristics by cohort
| Measure |
CP-690,550 >=10 mg
n=48 Participants
Participants who had received 1 dose CP-690,550 greater than or equal to (\>=) 10 milligram (mg) orally twice daily in any of the previous studies.
|
CP-690,550 <10 mg
n=89 Participants
Participants who had received 1 dose CP-690,550 less than (\<) 10 mg orally twice daily in any of the previous studies.
|
Placebo
n=22 Participants
Participants who had received 1 dose of matching-placebo in any of the previous studies.
|
Adalimumab
n=3 Participants
Participants who had received 1 dose of adalimumab in any of the previous studies.
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
57.2 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 16.0 • n=4 Participants
|
55.0 years
STANDARD_DEVIATION 11.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
132 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to Month 24Population: Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.
Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with LPD by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.
Outcome measures
| Measure |
CP-690,550 >=10 mg
n=48 Participants
Participants who had received 1 dose CP-690,550 greater than or equal to (\>=) 10 milligram (mg) orally twice daily in any of the previous studies.
|
CP-690,550 <10 mg
n=89 Participants
Participants who had received 1 dose CP-690,550 less than (\<) 10 mg orally twice daily in any of the previous studies.
|
Placebo
n=22 Participants
Participants who had received 1 dose of matching-placebo in any of the previous studies.
|
Adalimumab
n=3 Participants
Participants who had received 1 dose of adalimumab in any of the previous studies.
|
|---|---|---|---|---|
|
Incidence of Lymphoproliferative Disorders (LPD)
|
NA LPD per 100 person-years
Data was not analyzed as no LPD occurred.
|
NA LPD per 100 person-years
Data was not analyzed as no LPD occurred.
|
NA LPD per 100 person-years
Data was not analyzed as no LPD occurred.
|
NA LPD per 100 person-years
Data was not analyzed as no LPD occurred.
|
PRIMARY outcome
Timeframe: Up to Month 24Population: Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.
Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with lymphoma by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.
Outcome measures
| Measure |
CP-690,550 >=10 mg
n=48 Participants
Participants who had received 1 dose CP-690,550 greater than or equal to (\>=) 10 milligram (mg) orally twice daily in any of the previous studies.
|
CP-690,550 <10 mg
n=89 Participants
Participants who had received 1 dose CP-690,550 less than (\<) 10 mg orally twice daily in any of the previous studies.
|
Placebo
n=22 Participants
Participants who had received 1 dose of matching-placebo in any of the previous studies.
|
Adalimumab
n=3 Participants
Participants who had received 1 dose of adalimumab in any of the previous studies.
|
|---|---|---|---|---|
|
Incidence of Lymphoma
|
NA Lymphoma per 100 person-years
Data was not analyzed as no lymphoma occurred.
|
NA Lymphoma per 100 person-years
Data was not analyzed as no lymphoma occurred.
|
NA Lymphoma per 100 person-years
Data was not analyzed as no lymphoma occurred.
|
NA Lymphoma per 100 person-years
Data was not analyzed as no lymphoma occurred.
|
PRIMARY outcome
Timeframe: Up to Month 24Population: Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.
Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with important infections by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.
Outcome measures
| Measure |
CP-690,550 >=10 mg
n=48 Participants
Participants who had received 1 dose CP-690,550 greater than or equal to (\>=) 10 milligram (mg) orally twice daily in any of the previous studies.
|
CP-690,550 <10 mg
n=89 Participants
Participants who had received 1 dose CP-690,550 less than (\<) 10 mg orally twice daily in any of the previous studies.
|
Placebo
n=22 Participants
Participants who had received 1 dose of matching-placebo in any of the previous studies.
|
Adalimumab
n=3 Participants
Participants who had received 1 dose of adalimumab in any of the previous studies.
|
|---|---|---|---|---|
|
Incidence of Important Infections
|
0.000 Infections per 100 person-years
Interval 0.0 to
Upper limit of 95 percent (%) confidence interval (CI) was not estimable as no event occurred in this arm group.
|
0.607 Infections per 100 person-years
Interval 0.086 to 4.312
|
0.000 Infections per 100 person-years
Interval 0.0 to
Upper limit of 95 percent (%) confidence interval (CI) was not estimable as no event occurred in this arm group.
|
0.000 Infections per 100 person-years
Interval 0.0 to
Upper limit of 95 percent (%) confidence interval (CI) was not estimable as no event occurred in this arm group.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 6, 12, 18, 24Population: Safety analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for the measure and 'n' signifies participants evaluable at each time point for each arm respectively.
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 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 where 0 = least difficulty and 3 = extreme difficulty.
Outcome measures
| Measure |
CP-690,550 >=10 mg
n=48 Participants
Participants who had received 1 dose CP-690,550 greater than or equal to (\>=) 10 milligram (mg) orally twice daily in any of the previous studies.
|
CP-690,550 <10 mg
n=88 Participants
Participants who had received 1 dose CP-690,550 less than (\<) 10 mg orally twice daily in any of the previous studies.
|
Placebo
n=22 Participants
Participants who had received 1 dose of matching-placebo in any of the previous studies.
|
Adalimumab
n=3 Participants
Participants who had received 1 dose of adalimumab in any of the previous studies.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Month 12 (n= 39, 79, 21, 1)
|
1.16 units on a scale
Standard Deviation 0.63
|
1.12 units on a scale
Standard Deviation 0.76
|
1.15 units on a scale
Standard Deviation 0.81
|
0.88 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Month 18 (n= 35, 76, 20, 0)
|
1.15 units on a scale
Standard Deviation 0.59
|
1.07 units on a scale
Standard Deviation 0.77
|
1.12 units on a scale
Standard Deviation 0.86
|
NA units on a scale
Standard Deviation NA
Data was not analyzed as no participants were evaluable in this arm group.
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Month 24 (n= 31, 68, 20, 0)
|
1.15 units on a scale
Standard Deviation 0.69
|
1.14 units on a scale
Standard Deviation 0.78
|
1.07 units on a scale
Standard Deviation 0.87
|
NA units on a scale
Standard Deviation NA
Data was not analyzed as no participants were evaluable in this arm group.
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Baseline (n= 48, 88, 22, 3)
|
1.32 units on a scale
Standard Deviation 0.67
|
1.42 units on a scale
Standard Deviation 0.67
|
1.63 units on a scale
Standard Deviation 0.76
|
1.13 units on a scale
Standard Deviation 0.13
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Month 6 (n= 37, 81, 21, 2)
|
1.08 units on a scale
Standard Deviation 0.61
|
1.23 units on a scale
Standard Deviation 0.69
|
1.21 units on a scale
Standard Deviation 0.82
|
0.19 units on a scale
Standard Deviation 0.27
|
Adverse Events
CP-690,550 >=10 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CP-690,550 <10 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Adalimumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CP-690,550 >=10 mg
n=48 participants at risk
Participants who had received 1 dose CP-690,550 greater than or equal to (\>=) 10 milligram (mg) orally twice daily in any of the previous studies.
|
CP-690,550 <10 mg
n=89 participants at risk
Participants who had received 1 dose CP-690,550 less than (\<) 10 mg orally twice daily in any of the previous studies.
|
Placebo
n=22 participants at risk
Participants who had received 1 dose of matching-placebo in any of the previous studies.
|
Adalimumab
n=3 participants at risk
Participants who had received 1 dose of adalimumab in any of the previous studies.
|
|---|---|---|---|---|
|
Infections and infestations
Tuberculosis
|
0.00%
0/48
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.
|
1.1%
1/89
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.
|
0.00%
0/22
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.
|
0.00%
0/3
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.
|
Other adverse events
| Measure |
CP-690,550 >=10 mg
n=48 participants at risk
Participants who had received 1 dose CP-690,550 greater than or equal to (\>=) 10 milligram (mg) orally twice daily in any of the previous studies.
|
CP-690,550 <10 mg
n=89 participants at risk
Participants who had received 1 dose CP-690,550 less than (\<) 10 mg orally twice daily in any of the previous studies.
|
Placebo
n=22 participants at risk
Participants who had received 1 dose of matching-placebo in any of the previous studies.
|
Adalimumab
n=3 participants at risk
Participants who had received 1 dose of adalimumab in any of the previous studies.
|
|---|---|---|---|---|
|
Infections and infestations
Herpes zoster
|
4.2%
2/48
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.
|
0.00%
0/89
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.
|
0.00%
0/22
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.
|
0.00%
0/3
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.
|
|
Infections and infestations
Pneumonia
|
2.1%
1/48
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.
|
0.00%
0/89
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.
|
0.00%
0/22
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.
|
0.00%
0/3
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.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/48
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.
|
0.00%
0/89
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.
|
4.5%
1/22
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.
|
0.00%
0/3
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.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/48
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.
|
2.2%
2/89
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.
|
4.5%
1/22
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.
|
0.00%
0/3
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER