Study BCD-085-8/PATERA is a multicentre double-blind placebo-controlled Phase 3 study in patients with psoriatic arthritis (PsA). The objective of the study is to evaluate the efficacy and safety of BCD-085 comparing to placebo in patients with PsA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
194
1st City Clinical Hospital
Minsk, Belarus
Chelyabinsk Regional Clinical hospital
Chelyabinsk, Russia
North-Western State Medical University n.a. I.I.Mechnikov
Saint Petersburg, Russia
ACR 20
The percentage of patients achieved 20% improvement according to American College of Rheumatology response criteria. The ACR Criteria is a dichotomous variable with a positive (=responder) or negative (=non-responder) outcome. The ACR Criteria measures improvement in tender / swollen joint counts and improvement in at least three of the following parameters: 1) patient assessment 2) physician assessment 3) pain scale 4) disability/functional questionnaire 5) acute phase reactant (ESR or CRP). ACR 20 / 50 / 70 has a positive outcome if 20% / 50% / 70% improvement in tender and swollen joint counts was achieved as well as a 20% / 50% / 70% improvement in at least three of the other five criteria.
Time frame: week 24
ACR 20
The percentage of patients achieved 20% improvement according to American College of Rheumatology response criteria.
Time frame: Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
ACR 50
The percentage of patients achieved 50% improvement according to American College of Rheumatology response criteria.
Time frame: Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
ACR 70
The percentage of patients achieved 70% improvement according to American College of Rheumatology response criteria.
Time frame: Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
Proportion of patients achieved PsARC (Psoriatic Arthritis Response Criteria)
Time frame: Week 1, 2, 4, 8, 12, 16, 20, 24, 30, 38, 46, 54
Change in radiological signs of arthritis (mTSS)
mTSS - modified Total Sharp Score
Time frame: Week 24 and 54
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Proportion of patients with anti-drug antibodies
Time frame: Week 2, Week 12, Week 24, Week 38, Week 54