A prospective, randomized, controlled, open label, assessor-blinded, parallel-group Phase III clinical trial to evaluate the impact of tapering systemic immunosuppressive therapy in a treat-to-target approach on maintaining minimal disease activity in adult subjects with psoriatic arthritis

Conditions

Psoriatic arthritis

Brief summary

Presence of minimal disease activity (MDA ) 12 months after baseline., Mean PASDAS at month-12.

Detailed description

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

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGSULFASALAZINE

DRUGCimzia 200 mg solution for injection in pre-filled syringe

DRUGADALIMUMAB

DRUGSTELARA 45 mg solution for injection

DRUGOtezla 30 mg film-coated tablets

DRUGTremfya 100 mg solution for injection in pre-filled pen.

DRUGINFLIXIMAB

DRUGXELJANZ 5 mg film-coated tablets

DRUGCimzia 200 mg solution for injection in dose-dispenser cartridge

DRUGLEFLUNOMIDE

DRUGCosentyx 150 mg solution for injection in pre-filled pen

DRUGORENCIA 125 mg solution for injection in pre-filled pen

DRUGXELJANZ 11 mg prolonged-release tablets

DRUGPREDNISOLONE

DRUGMETHOTREXATE DISODIUM

DRUGETANERCEPT

DRUGORENCIA 125 mg solution for injection in pre-filled syringe

DRUGCimzia 200 mg solution for injection in pre-filled pen

DRUGORENCIA 250 mg powder for concentrate for solution for infusion

DRUGTaltz 80 mg solution for injection in pre-filled pen

DRUGCosentyx 150 mg solution for injection in pre-filled syringe

DRUGSkyrizi 150 mg solution for injection in pre-filled syringe

DRUGRINVOQ 15 mg prolonged-release tablets

DRUGSimponi 50 mg solution for injection in pre-filled syringe.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Presence of minimal disease activity (MDA ) 12 months after baseline., Mean PASDAS at month-12.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany, Italy

Outcome results

None listed