Arthritis, Rheumatoid
Conditions
Keywords
Observational non-interventional long-term safety
Brief summary
The purpose of this study is to follow the health of subjects who have previously been enrolled in studies of CP-690,550 for treatment of their rheumatoid arthritis. Subjects are only eligible for this study after they have completed all participation in other studies of CP-690,550.
Detailed description
At their last visit of a qualifying study, eligible subjects will be given the opportunity to participate in this study.
Interventions
DRUGCP-690,550
Subjects had to have received CP-690,550 or other blinded study drug in index study. No intervention in this long-term follow-up trial.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who have completed all participation in any other Phase 2B or Phase 3 studies of CP-690,550 for rheumatoid arthritis.
Exclusion criteria
* Any subject who refuses consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Lymphoproliferative Disorders (LPD) | Up to Month 24 | 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. |
| Incidence of Lymphoma | Up to Month 24 | 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. |
| Incidence of Important Infections | Up to Month 24 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline, Month 6, 12, 18, 24 | 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. |
Countries
Argentina, Brazil, Bulgaria, Canada, Chile, Czechia, Dominican Republic, Finland, Greece, Hungary, India, Italy, Japan, Mexico, Poland, Puerto Rico, Slovakia, South Korea, Spain, Ukraine, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 48 |
| 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. | 89 |
| Placebo Participants who had received 1 dose of matching-placebo in any of the previous studies. | 22 |
| Adalimumab Participants who had received 1 dose of adalimumab in any of the previous studies. | 3 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 2 | 5 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 4 | 0 | 1 |
| Overall Study | Other | 6 | 3 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | CP-690,550 >=10 mg | CP-690,550 <10 mg | Placebo | Adalimumab | Total |
|---|---|---|---|---|---|
| Age Continuous | 57.2 years STANDARD_DEVIATION 10.8 | 54.7 years STANDARD_DEVIATION 11.6 | 51.8 years STANDARD_DEVIATION 13.5 | 52.3 years STANDARD_DEVIATION 16 | 55.0 years STANDARD_DEVIATION 11.7 |
| Sex: Female, Male Female | 40 Participants | 72 Participants | 17 Participants | 3 Participants | 132 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 5 Participants | 0 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 48 | 2 / 89 | 1 / 22 | 0 / 3 |
| serious Total, serious adverse events | 0 / 48 | 1 / 89 | 0 / 22 | 0 / 3 |
Outcome results
Primary
Incidence of Important Infections
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.
Time frame: Up to Month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 >=10 mg | Incidence of Important Infections | 0.000 Infections per 100 person-years |
| CP-690,550 <10 mg | Incidence of Important Infections | 0.607 Infections per 100 person-years |
| Placebo | Incidence of Important Infections | 0.000 Infections per 100 person-years |
| Adalimumab | Incidence of Important Infections | 0.000 Infections per 100 person-years |
Primary
Incidence of Lymphoma
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.
Time frame: Up to Month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 >=10 mg | Incidence of Lymphoma | NA Lymphoma per 100 person-years |
| CP-690,550 <10 mg | Incidence of Lymphoma | NA Lymphoma per 100 person-years |
| Placebo | Incidence of Lymphoma | NA Lymphoma per 100 person-years |
| Adalimumab | Incidence of Lymphoma | NA Lymphoma per 100 person-years |
Primary
Incidence of Lymphoproliferative Disorders (LPD)
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.
Time frame: Up to Month 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 >=10 mg | Incidence of Lymphoproliferative Disorders (LPD) | NA LPD per 100 person-years |
| CP-690,550 <10 mg | Incidence of Lymphoproliferative Disorders (LPD) | NA LPD per 100 person-years |
| Placebo | Incidence of Lymphoproliferative Disorders (LPD) | NA LPD per 100 person-years |
| Adalimumab | Incidence of Lymphoproliferative Disorders (LPD) | NA LPD per 100 person-years |
Other Pre-specified
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
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.
Time frame: Baseline, Month 6, 12, 18, 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 >=10 mg | 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 |
| CP-690,550 >=10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline (n= 48, 88, 22, 3) | 1.32 units on a scale | Standard Deviation 0.67 |
| CP-690,550 >=10 mg | 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 |
| CP-690,550 >=10 mg | 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 |
| CP-690,550 >=10 mg | 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 |
| CP-690,550 <10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Month 24 (n= 31, 68, 20, 0) | 1.14 units on a scale | Standard Deviation 0.78 |
| CP-690,550 <10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Month 6 (n= 37, 81, 21, 2) | 1.23 units on a scale | Standard Deviation 0.69 |
| CP-690,550 <10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline (n= 48, 88, 22, 3) | 1.42 units on a scale | Standard Deviation 0.67 |
| CP-690,550 <10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Month 12 (n= 39, 79, 21, 1) | 1.12 units on a scale | Standard Deviation 0.76 |
| CP-690,550 <10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Month 18 (n= 35, 76, 20, 0) | 1.07 units on a scale | Standard Deviation 0.77 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline (n= 48, 88, 22, 3) | 1.63 units on a scale | Standard Deviation 0.76 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Month 12 (n= 39, 79, 21, 1) | 1.15 units on a scale | Standard Deviation 0.81 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Month 6 (n= 37, 81, 21, 2) | 1.21 units on a scale | Standard Deviation 0.82 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Month 18 (n= 35, 76, 20, 0) | 1.12 units on a scale | Standard Deviation 0.86 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Month 24 (n= 31, 68, 20, 0) | 1.07 units on a scale | Standard Deviation 0.87 |
| Adalimumab | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Month 24 (n= 31, 68, 20, 0) | NA units on a scale | — |
| Adalimumab | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline (n= 48, 88, 22, 3) | 1.13 units on a scale | Standard Deviation 0.13 |
| Adalimumab | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Month 6 (n= 37, 81, 21, 2) | 0.19 units on a scale | Standard Deviation 0.27 |
| Adalimumab | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Month 12 (n= 39, 79, 21, 1) | 0.88 units on a scale | — |
| Adalimumab | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Month 18 (n= 35, 76, 20, 0) | NA units on a scale | — |