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 Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02988674
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

AbbVie Inc.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Russian Federation
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Spondylarthritis, Psoriatic Arthritis, Ankylosing Spondylitis (AS)
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Kemerovo, Kemerovskaya Oblast, Russian Federation

Status

Recruiting

Address

Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 167025

Kemerovo, Kemerovskaya Oblast, 650066

Moscow, Moskva, Russian Federation

Status

Not yet recruiting

Address

Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 154379

Moscow, Moskva, 119049

Chelyabinsk, Russian Federation

Status

Not yet recruiting

Address

Chelyabinsk Regional Clin Hosp /ID# 167026

Chelyabinsk, , 454092

Ivanovo, Russian Federation

Status

Recruiting

Address

Ivanovo Regional Clinical Hosp /ID# 167028

Ivanovo, , 153040

Institution KhMAO-Ugra /ID# 154381, Khanty-mansiysk, Russian Federation

Status

Recruiting

Address

Institution KhMAO-Ugra /ID# 154381

Khanty-mansiysk, , 628011

State Clinical policlinic /ID# 154374, Moscow, Russian Federation

Status

Recruiting

Address

State Clinical policlinic /ID# 154374

Moscow, , 107023

Central Research Institute /ID# 154375, Moscow, Russian Federation

Status

Recruiting

Address

Central Research Institute /ID# 154375

Moscow, , 111123

Research Institute of Rheum /ID# 154378, Moscow, Russian Federation

Status

Completed

Address

Research Institute of Rheum /ID# 154378

Moscow, , 115522

Advisory-diagnostic Hospital /ID# 154382, Moscow, Russian Federation

Status

Recruiting

Address

Advisory-diagnostic Hospital /ID# 154382

Moscow, , 117041

State Clinical Hospital /ID# 154373, Moscow, Russian Federation

Status

Recruiting

Address

State Clinical Hospital /ID# 154373

Moscow, , 119049

Moscow, Russian Federation

Status

Not yet recruiting

Address

Diagnostic Center # 5 of Mosco /ID# 154377

Moscow, , 127572

GBUZ Republican Hospital /ID# 167029, Petrozavodsk, Russian Federation

Status

Recruiting

Address

GBUZ Republican Hospital /ID# 167029

Petrozavodsk, , 185019

Smolensk, Russian Federation

Status

Not yet recruiting

Address

Smolensk station JSC Russian R /ID# 167027

Smolensk, , 214025

St. Petersburg, Russian Federation

Status

Recruiting

Address

Nort-Western State Medical Uni /ID# 154376

St. Petersburg, , 191015

Tula, Russian Federation

Status

Recruiting

Address

Tula Regional Clinical Hospita /ID# 155539

Tula, , 300053

Yaroslavl, Russian Federation

Status

Recruiting

Address

Yaroslavi State Medical Univer /ID# 154383

Yaroslavl, , 150000

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