Trial · NCT04610476
Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis
NCT04610476, Phase 3, Unknown, University of Erlangen-Nürnberg Medical School
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis. Trials, record NCT04610476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04610476
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis
- NCT number
- NCT04610476
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 270 participants, estimated
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Conditions
- Psoriatic Arthritis, Withdrawal, Reduction
- Interventions
- Prednisolone, Sulfasalazine, Leflunomide, Methotrexate, Tofacitinib, Apremilast, Etanercept, Adalimumab, Infliximab, Certolizumab pegol, Golimumab, Abatacept, Secukinumab, Ixekizumab, Ustekinumab
- First posted
- 2020-10-30
- Last updated
- 2022-11-14
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Presence of MDA (minimal disease activity) 12 months after baseline. | 12 months | The MDA status comprises the assessment of different domains of PsA, consisting of the following individual components: * swollen and tender joint count * tender entheseal point count * skin involvement (PASI)patient self-assessment of pain (VAS) * global disease activity status * subject's self-assessment of functional ability using Stanford Health Assessment Questionnaire disability index, (HAQ-DI) MDA is defined as the presence of 5 of the following 7 criteria: 1. tender joint count ≤1 2. swollen joint count ≤1 3. tender entheseal point count ≤1 (means: remission) 4. PASI ≤1 OR body surface area (BSA) ≤3% 5. patient pain VAS ≤15 6. patient global activity VAS ≤20 7. HAQ-DI ≤0.5 |
| Secondary | Key secondary endpoint: PASDAS (Psoriatic Arthritis Disease Activity Score) | 12 months | The PASDAS is a composite disease activity index (range 0-10) for psoriatic arthritis (PsA) incorporating seven domains: patient and physician global activity VAS scores, tender and swollen joint counts (arthritis), dactylitis, enthesitis (Leeds), health-related QoL (SF-36), and CRP level. PASDAS has demonstrated to have a better discriminate capacity in distinguishing high and low disease activity. The PASDAS is computed by the following equation: PASDAS = (((0, 18 ∗ ∗√(PhGA) + 0.159 ∗ ∗√(PtGA) - 0.253 ∗ ∗√(SF36 -PCS) + 0.101 ∗ lognat(SJC66 + 1)) + 0.048 ∗ lognat(SJC68 +1)) + 0.23 ∗ lognat (Leeds enthesitis index + 1)) + 0.37 ∗lognat (tender dactylitis count + 1) + 0.102 ∗ lognat (CRP +1) + 2 ∗ 1.5. |
| Secondary | Key secondary endpoint: DAPSA (Disease Activity in PSoriatic Arthritis) | 12 months | The DAPSA score determines changes in the disease activity of subjects diagnosed with PsA. DAPSA is a composite score which is calculated from the sum of: number of tender joints (0-68), number of swollen joints (0-66, hips are not taken into account), CRP (mg/dl), subject's assessment of global status of disease activity using VAS (0-10) and patient's self-assessment of pain using VAS (0-10). A value of the composite score DAPSA 0-≤ 4 marks remission, 5-14 marks low, 15-28 moderate and \>28 high disease activity |
| Secondary | Key secondary endpoint: CPDAI (Composite Psoriatic Disease Activity Index) | 12 months | The composite psoriatic disease activity index (CPDAI) assesses disease activity under five domains using well established and validated instruments of PsA disease documentation as proposed by GRAPPA. The domains and the respective instrument are as follows: joint disease (SJC/TJC, HAQ), skin involvement (PASI, DLQI), enthesitis (LEI, HAQ), dactylitis (dactylitis digit count, HAQ) and spinal involvement (BASDAI and ASQoL). Using the instruments and ranges of values, disease activity under each domain is graded as none (0) -mild (1) -moderate (2) and severe (3) giving a range attainable CPDAI scores of between 0 and 15. The CPDAI correlates well with patient and physician global disease activity assessments and is an effective tool that clearly distinguishes those who require a treatment change from those who do not. |
| Secondary | Number of swollen and tender joints | 12 months | An assessment of 66 joints for swelling and 68 joints for tenderness will be made (including the DIP joints of the hands and excluding hips for swelling). |
| Secondary | Number of tender entheseal points: SPARCC (Spondyloarthritis Consortium of Canada) | 12 months | The SPARCC enthesitis score is based on the counting of the presence or absence of tenderness on 16 entheseal sites (eight sites on each body side, respectively): lateral epicondyle, medial epicondyle, supraspinatus insertion into greater tuberosity of humerus, greater trochanter, quadriceps insertion into superior borders of patella, patellar ligament insertion into inferior pole of patella or tibial tubercle, Achilles tendon insertion into calcaneum, and plantar fascia insertion into calcaneum. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, summarized in an overall score ranging from 0 to 16. A higher count represents a greater enthesitis burden |
| Secondary | Number of tender entheseal Points: LEI (Leeds Enthesitis Index) | 12 months | The LEI includes 3 entheseal sites on each body side, respectively: lateral epicondyles, medial condyles of the femur, and Achilles tendons. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 6 sites, for in an overall score ranging from 0 to 6. A higher count represents a greater enthesitis burden |
| Secondary | Number of tender entheseal Points: MASES (Maastricht Ankylosing Spondylitis Enthesitis Score) | 12 months | The MASES includes 6 entheseal sites on each body side (first costochondral joints, seventh costochondral joints, posterior superior iliac spines, anterior superior iliac spines, iliac crests, proximal insertion of Achilles tendons) and in addition the fifth lumbar spinous process. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 13 sites, for an overall score ranging from 0 to 13. A higher count represents a greater enthesitis burden |
| Secondary | Dactylitis counts | 12 months | The presence of dactylitis will be assessed by counting the fingers/toes with dactylitis. |
| Secondary | Activity of psoriasis: PASI (Psoriasis Area and Severity Index) | 12 months | PASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 (no disease) to 72 (maximal disease). |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT04610476/registered?page=2