A Study to Assess Retention Rate, Persistence and Adherence in Population of Spondylarthritis (Ankylosing Spondylitis and Psoriatic Arthritis) Patients Treated With Adalimumab in Routine Clinical Settings in Russian Federation

Study Identifier
P15-672
CT.gov Identifier
NCT02988674
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Axial Spondyloarthritis (axSpA)
  • Psoriatic Arthritis (PsA)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Confirmed diagnosis of AS or PsA. * Planned prescription or prescribed no more than 1 month before to enrolment therapy with adalimumab. Treatment has to be prescribed according to the local product label and prescription guidelines. * At the moment of start of treatment with adalimumab moderate/severe AS or PsA (BASDAI \> 4 for AS; DAS28 \>3,2 for PsA). * Negative result of tuberculosis (TB) screening test and TB specialist permission to start biologic therapy. * Authorization (Consent) for Use/Disclosure of Data signed by the participant.
    Exclusion Criteria:
    * Has contraindications for the treatment with adalimumab (please see the latest version of the locally approved label). * Participants who are unable to walk and perform basic self-care activities either due to SpA or a comorbid condition. * Any biologic drugs taken over before 3 months of enrolment to the study. * Previous participation in this program.

    Protocol Summary

    The objective of this study is to access retention rate, persistence and adherence in population of spondylarthritis (SpA) (ankylosing spondylitis (AS) and psoriatic arthritis (PsA)) participants treated with adalimumab in routine clinical settings in the Russian Federation.

    Study Locations

    Location
    Status
    Location
    Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 167025
    Kemerovo, Kemerovo Oblast, Russian Federation, 650066
    Status
    Not applicable
    Location
    Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 154379
    Moscow, Moscow, Russian Federation, 119049
    Status
    Not applicable
    Location
    Ivanovo Regional Clinical Hosp /ID# 167028
    Ivanovo, Russian Federation, 153040
    Status
    Not applicable
    Location
    Institution KhMAO-Ugra /ID# 154381
    Khanty-Mansiysk, Russian Federation, 628011
    Status
    Not applicable
    Location
    State Clinical policlinic /ID# 154374
    Moscow, Russian Federation, 107023
    Status
    Not applicable
    Location
    Central Research Institute /ID# 154375
    Moscow, Russian Federation, 111123
    Status
    Not applicable
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