Psoriatic arthritis MedDRA version: 21.1 Level: PT Classification code 10037162 Term: Psoriatic arthropathy System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Prednisolone p.o.
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of PsA according to CASPAR criteria - male or female adult subject; age >=18 years - Disease status “MDA” for at least 6 months; MDA is defined as the presence of 5 of the following 7 criteria: a) tender joint count =1 b) swollen joint count =1 c) tender entheseal point count =1 (means: remission) d) PASI =1 or body surface area =3 e) patient pain VAS =15 f) patient global activity VAS =20 g) HAQ-DI =0.5 - Disease Status "MDA+"; MDA+ is defined as the presence of 5 of the 7 criteria for MDA, whereby all musculoskeletal Domains a)-c) must fulfil the criteria -suject should have been treated without alterations of therapy (fixed dose and drug) for at least 6 months with one or more of the following drugs: i. csDMARD Leflunomid (e.g. Arava), Sulfasalazin (e.g. Azulfidine RA, Pleon RA), Methotrexate (e.g. Lantarel, Metex) AND/OR ii. bDMARD/tsDMARD: Etanercept (e.g. Enbrel, Erelzi, Benepali), Adalimumab (e.g. Humira, Amgevita, Imraldi, Hyrimoz), Infliximab (e.g. Remicade, Zessly, Inflectra), Golimumab (Simponi), Certolizumab (Cimzia), Abatacept (Orencia), Apremilast (Otezla), Ustekinumab (Stelara), Secukinumab (Cosentyx), Ixekizumab (Taltz), Guselkumab (Tremfya), Upadacitinib (Rinvoq), Risankizumab (Skyrizi), Tofacitinib (Xeljanz) AND/OR (c) glucocorticoids (=5mg prednisolone equivalent). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: - Diagnosis of any other rheumatological/ immunological disease such as rheumatoid arthritis, SLE, PSS, MCTD, M. Behcet or M. Wegener - Concomitant florid immune mediated disease such as autoimmune Hepatitis that is untreated and/or requires immunosuppressive treatment - Use of any inadmissible medication (e.g. current treatment with DMARDs other than mentioned above or drugs under development) - Treatment with systemic glucocorticoids (daily dose >5mg prednisolone equivalent) during the last 6 months before randomization. Intra-articular or entheseal injections of glucocorticoids do not constitute an exclusion criterion - Malignant disease or history of malignant disease within 5 years prior to screening, which could affect the reduction of immunosuppressive therapy - Existence of another disease including the presence of laboratory abnormalities which, at the discretion of the investigator, would result in a disproportionate risk to the patient concerned or confounds the ability to interpret data from the study - Any anti-inflammatory (excluding NSAIDs) or immunosuppressive therapy for other reasons than PsA or psoriasis during the last 3 months before screening - Nursing mother or pregnant woman as verified by a positive pregnancy test - Known hypersensitivity to the IMPs or any of their formulation ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the impact of tapering systemic immunosuppressive therapy in a treat-to-target approach on maintaining minimal disease activity (MDA) in adult subjects with psoriatic arthritis (PsA) and stable MDA;Secondary Objective: • To investigate the effects of tapering systemic immunosuppressive therapy on multidimensional aspects of PsA disease activity • To investigate the effects of tapering systemic immunosuppressive therapy on subject safety ;Primary end point(s): - Presence of minimal disease activity (MDA ) - Mean PASDAS ;Timepoint(s) of evaluation of this end point: 12 months after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Key secondary endpoints: PASDAS, DAPSA and mCPDAI - Number of swollen and tender joints - Number of tender entheseal points (SPARCC, LEI, MASES entheseal point counts) - Dactylitis counts - Activity of psoriasis (PASI, BSA) - Activity of axial involvement (BASDAI) - Quality of life and health/disability (PsAID-12, HAQ-DI, DLQI, ASQoL, SF-36) - Pain (VAS) - Proportion of patients with loss of MDA within 12 months after baseline - Proportion of patients with loss of MDA within 24 months after baseline - Time to loss of MDA - Time needed to restore MDA after readjustment of the DMARD therapy in subjects who lost MDA within the intervention period - Biomarker levels - Intervention-related events within the observation period of 24 months after baseline - AE, AR, SAE, SAR, SUSAR - Subjective (SACRAH, DASH, MHQshort) and objective (grip strength (lbf) and moberg-pick up test (s) hand function ;Timepoint(s) of evaluation of this end point: 12 (24) months after baseline | — |
Countries
Germany
Contacts
Public ContactMedizinische Klinik 3
Universitätsklinikum Erlangen
Outcome results
None listed