Trial Outcomes & Findings for Psoriatic Arthritis Research Collaborative: Biologic Sub-Study (NCT NCT03378336)
NCT ID: NCT03378336
Last Updated: 2025-05-09
Results Overview
Patient's perception of response to therapy as related to patient functionality. Measured by a change in RAPID3 score from baseline to 3 month visit. RAPID3 (Routine Assessment of Patient Index Data 3) is a pooled index of the 3 patient-reported American College of Rheumatology Core Data Set measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30. Disease severity may be classified on the basis of RAPID3 scores: \>12 = high; 6.1-12 = moderate; 3.1-6 = low; \< or =3 = remission.
COMPLETED
171 participants
3 Months
2025-05-09
Participant Flow
171 unique participants were enrolled in the study, but there were 266 instances of treatment initiation analyzed (each participant could initiate \>1 therapy). Of the 266 instances of treatment initiation, not all outcome measures were completed at both Baseline and Month 3. Therefore, some outcome measures have a smaller number of units analyzed to include only those completed at both timepoints.
Unit of analysis: Treatment Initiations
Participant milestones
| Measure |
Participants With PsA Starting a New Therapy
This is an observational study with only one group - participants with PsA starting a new therapy.
|
|---|---|
|
Overall Study
STARTED
|
171 266
|
|
Overall Study
COMPLETED
|
171 266
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psoriatic Arthritis Research Collaborative: Biologic Sub-Study
Baseline characteristics by cohort
| Measure |
Observational Group
n=266 treatment initiations
This is an observational study with only one group/cohort with no intervention
|
|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 13.8 • n=266 treatment initiations
|
|
Sex: Female, Male
Female
|
140 treatment initiations
n=266 treatment initiations
|
|
Sex: Female, Male
Male
|
126 treatment initiations
n=266 treatment initiations
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 treatment initiations
n=266 treatment initiations
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
229 treatment initiations
n=266 treatment initiations
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 treatment initiations
n=266 treatment initiations
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 treatment initiations
n=266 treatment initiations
|
|
Race (NIH/OMB)
Asian
|
1 treatment initiations
n=266 treatment initiations
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 treatment initiations
n=266 treatment initiations
|
|
Race (NIH/OMB)
Black or African American
|
1 treatment initiations
n=266 treatment initiations
|
|
Race (NIH/OMB)
White
|
242 treatment initiations
n=266 treatment initiations
|
|
Race (NIH/OMB)
More than one race
|
0 treatment initiations
n=266 treatment initiations
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 treatment initiations
n=266 treatment initiations
|
|
Tender joint count
|
5.8 joints
STANDARD_DEVIATION 7.4 • n=266 treatment initiations
|
|
Swollen joint count
|
2.9 joints
STANDARD_DEVIATION 4.9 • n=266 treatment initiations
|
|
Body surface area (%)
|
1.6 %
STANDARD_DEVIATION 3.9 • n=266 treatment initiations
|
|
Enthesitis count
|
0.6 entheses
STANDARD_DEVIATION 1.1 • n=266 treatment initiations
|
|
Dactylitis count
|
0.3 digits
STANDARD_DEVIATION 1.2 • n=266 treatment initiations
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: 225 completed RAPID3 at Baseline and Month 3
Patient's perception of response to therapy as related to patient functionality. Measured by a change in RAPID3 score from baseline to 3 month visit. RAPID3 (Routine Assessment of Patient Index Data 3) is a pooled index of the 3 patient-reported American College of Rheumatology Core Data Set measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30. Disease severity may be classified on the basis of RAPID3 scores: \>12 = high; 6.1-12 = moderate; 3.1-6 = low; \< or =3 = remission.
Outcome measures
| Measure |
Observational Group
n=225 treatment initiations
This is an observational study with only one group/cohort with no intervention
|
|---|---|
|
Patient Function Response to Biologic Therapy as Measured by RAPID3
|
-1.11 change in score
Standard Deviation 5.26
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 85 participants completed HAQ-DI at Baseline and Month 3
Patient's perception of response to therapy as related to patient functionality. Measured by change in HAQ-DI score from baseline to 3 month visit. The HAQ-DI (Health Assessment Questionnaire - Disability Index) covers 20 items in eight domains related to measuring difficulty in performing activities of daily living. Each question is rated on a 0-3 scale, where 0 indicates "without difficulty" and 3 indicates "unable to do." The highest score in each domain is accepted as the score in that domain. Scores for the 8 domains are averaged to compute final score between 0 and 3. Scores 0-1 indicate mild to moderate disability, 1-2 indicate moderate to severe disability, and 2-3 indicate severe to very severe disability.
Outcome measures
| Measure |
Observational Group
n=85 treatment initiations
This is an observational study with only one group/cohort with no intervention
|
|---|---|
|
Patient Function Response to Biologic Therapy as Measured by HAQ-DI
|
-0.07 change in score
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 183 instances of therapy initiation completed PROMIS10 PH at Baseline and Month 3.
Patient's perception of response to therapy as related to quality of life. Measured by change in PROMIS10 Physical Health score from baseline to 3 month visit. PROMIS10 (Patient-Reported Outcomes Measurement Information System) Physical Health is a 10-item questionnaire, each with a five point scale from Poor to Excellent. PROMIS uses Item Response Theory (IRT) statistical model that links individual questions to a presumed underlying trait or concept of global health represented by all items in the scale; instruments are scored using item-level calibrations ("response pattern scoring") in an online tool (T-Score range 0-100). Increasing score indicates improvement.
Outcome measures
| Measure |
Observational Group
n=183 therapy initiation
This is an observational study with only one group/cohort with no intervention
|
|---|---|
|
Patient Quality of Life Response to Biologic Therapy as Measured by PROMIS10
|
1.43 change in score
Standard Deviation 6.20
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 225 instances of therapy initiation completed PSAID at Baseline and Month 3.
Patient's perception of response to therapy as related to quality of life. Measured by change in PSAID score from baseline to 3 month visit. PSAID (PsA Impact of Disease) is a questionnaire composed of 12 health domains, examining different perspectives (both physical and psychological). Each domain is evaluated by a single question with a range from 0-10 in which higher results indicate a greater impact of the disease. Individual domain scores are weighted to indicate those with a greater effect, then the sum of weighted domain scores is divided by 20 to compute the final score (range 0-10).
Outcome measures
| Measure |
Observational Group
n=225 therapy initiations
This is an observational study with only one group/cohort with no intervention
|
|---|---|
|
Patient Quality of Life Response to Biologic Therapy as Measured by PSAID
|
-0.30 change in score
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 256 instances of therapy initiation had swollen joint count measured at Baseline and Month 3
Physician assessment of disease activity as measured by change in swollen joint count from baseline to 3 months.
Outcome measures
| Measure |
Observational Group
n=256 therapy initiations
This is an observational study with only one group/cohort with no intervention
|
|---|---|
|
Physician Assessment of Disease Response to Biologic Therapy as Measured by Swollen Joint Count.
|
-0.81 change in joint count
Standard Deviation 4.71
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 256 instances of therapy initiation had tender joint count measured at Baseline and Month 3.
Physician assessment of disease activity as measured by change in tender joint count from baseline to 3 months.
Outcome measures
| Measure |
Observational Group
n=256 therapy initiations
This is an observational study with only one group/cohort with no intervention
|
|---|---|
|
Physician Assessment of Disease Response to Biologic Therapy as Measured by Tender Joint Count.
|
-0.63 change in joint count
Standard Deviation 8.35
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 234 instances of therapy initiation completed the Pt Pain assessment at Baseline and Month 3.
Disease Activity and Response to Biologic Therapy as measured by change in Patient Pain Assessment from baseline to 3 month visit. The Patient Pain Assessment is measured on a scale of 0-100 where a higher score indicates worse pain.
Outcome measures
| Measure |
Observational Group
n=234 therapy initiations
This is an observational study with only one group/cohort with no intervention
|
|---|---|
|
Disease Activity and Response to Biologic Therapy as Measured by Patient Pain Assessment
|
-0.75 change of score
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 249 instances of therapy initiation had a Physician Global Assessment at Baseline and Month 3.
Disease Activity and Response to Biologic Therapy as measured by change in Physician Global Assessment from baseline to 3 month visit. Physician Global Assessment is measured on a scale from 0-10 where a higher score indicates greater disease impact.
Outcome measures
| Measure |
Observational Group
n=249 therapy initiations
This is an observational study with only one group/cohort with no intervention
|
|---|---|
|
Disease Activity and Response to Biologic Therapy as Measured by Physician Global Assessment
|
-0.30 change in score
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 234 instances of therapy initiation completed the Pt Global assessment at Baseline and Month 3.
Disease Activity and Response to Biologic Therapy as measured by change in Patient Global Assessment from baseline to 3 month visit. Patient Global Assessment is measured on a scale of 0-10 where a higher score indicates greater disease impact.
Outcome measures
| Measure |
Observational Group
n=234 therapy initiations
This is an observational study with only one group/cohort with no intervention
|
|---|---|
|
Disease Activity and Response to Biologic Therapy as Measured by Patient Global Assessment
|
-0.24 change in score
Standard Deviation 2.66
|
Adverse Events
Observational Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place