NCT03378336: PARC-B

Psoriatic Arthritis Research Collaborative: Biologic Sub-Study

Completed Results posted Last updated 9 May 2025

What this trial tests

trial in Psoriatic Arthritis in 171 participants. Completed in 16 August 2023.

Timeline

31 December 2017

Primary endpoint
16 August 2023

16 August 2023

Quick facts

Lead sponsor	University of Pennsylvania
Status	Completed
Study type	OBSERVATIONAL
Enrollment	171
Start date	31 December 2017
Primary completion	16 August 2023
Estimated completion	16 August 2023
Sites	4 locations across United States

Conditions studied

• Psoriatic Arthritis — all drugs for Psoriatic Arthritis →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 89, any sex, with Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Function Response to Biologic Therapy as Measured by RAPID3 Primary · 3 Months

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.

Group	Value	95% CI
Observational Group	-1.11	± 5.26

Patient Function Response to Biologic Therapy as Measured by HAQ-DI Secondary · 3 Months

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 indicat

Group	Value	95% CI
Observational Group	-0.07	± 0.42

Patient Quality of Life Response to Biologic Therapy as Measured by PROMIS10 Secondary · 3 Months

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

Group	Value	95% CI
Participants With PsA Starting a New Therapy	1.43	± 6.20

Patient Quality of Life Response to Biologic Therapy as Measured by PSAID Secondary · 3 Months

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).

Group	Value	95% CI
Participants With PsA Starting a New Therapy	-0.30	± 1.05

Physician Assessment of Disease Response to Biologic Therapy as Measured by Swollen Joint Count. Secondary · 3 Months

Physician assessment of disease activity as measured by change in swollen joint count from baseline to 3 months.

Group	Value	95% CI
Participants With PsA Starting a New Therapy	-0.81	± 4.71

Physician Assessment of Disease Response to Biologic Therapy as Measured by Tender Joint Count. Secondary · 3 Months

Physician assessment of disease activity as measured by change in tender joint count from baseline to 3 months.

Group	Value	95% CI
Participants With PsA Starting a New Therapy	-0.63	± 8.35

Disease Activity and Response to Biologic Therapy as Measured by Patient Pain Assessment Secondary · 3 Months

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.

Group	Value	95% CI
Participants With PsA Starting a New Therapy	-0.75	± 2.66

Disease Activity and Response to Biologic Therapy as Measured by Physician Global Assessment Secondary · 3 Months

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.

Group	Value	95% CI
Participants With PsA Starting a New Therapy	-0.30	± 1.54

Disease Activity and Response to Biologic Therapy as Measured by Patient Global Assessment Secondary · 3 Months

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.

Group	Value	95% CI
Participants With PsA Starting a New Therapy	-0.24	± 2.66

Sponsor's own description

Psoriatic arthritis (PsA) is an inflammatory arthritis with substantial variation in clinical features. We propose a multicenter collaborative approach to better understand the phenotypes and current management of PsA in the United States.The central goal of this proposal is to obtain the data necessary to design a pragmatic trial in PsA.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A comparison of physical function instruments in psoriatic arthritis: HAQ-DI vs MDHAQ vs PROMIS10 global physical health.
   Wan MT, Walsh JA, Craig ET, Husni ME, et al · · 2021 · cited 8× · PMID 33313838 · DOI 10.1093/rheumatology/keaa591
2. Use of the Bath Ankylosing Spondylitis Disease Activity Index in Patients With Psoriatic Arthritis With and Without Axial Disease.
   Reddy SM, Xue K, Husni ME, Scher JU, et al · · 2024 · cited 6× · PMID 38101918 · DOI 10.3899/jrheum.2023-0504
3. Psoriatic arthritis phenotype clusters and their association with treatment response: a real-world longitudinal cohort study from the psoriatic arthritis research consortium.
   Karmacharya P, Crofford LJ, Byrne DW, Stephens-Shields A, et al · · 2025 · cited 3× · PMID 39919898 · DOI 10.1136/ard-2024-226150