SpondylarthritisAdherenceNCT02988674
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
An observational study of Spondylarthritis and Psoriatic Arthritis, run by AbbVie at 14 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Spondylarthritis, Psoriatic Arthritis, Ankylosing Spondylitis (AS)
- How many people
- 139 participants
- Where
- 14 sitesRussia
- Study dates
- 22 Dec 2016to 16 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) participants treated with adalimumab in routine clinical settings in the Russian Federation.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
14 sites in 1 country.
14 sites in 1 country
Russia14 sites
Ivanovo Regional Clinical Hosp /ID# 167028
Ivanovo, 153040
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 167025
Kemerovo, Kemerovo Oblast, 650066
Institution KhMAO-Ugra /ID# 154381
Khanty-Mansiysk, 628011
Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 154379
Moscow, Moscow, 119049
State Clinical policlinic /ID# 154374
Moscow, 107023
Central Research Institute /ID# 154375
Moscow, 111123
Research Institute of Rheum /ID# 154378
Moscow, 115522
Advisory-diagnostic Hospital /ID# 154382
Moscow, 117041
State Clinical Hospital /ID# 154373
Moscow, 119049
GBUZ Republican Hospital /ID# 167029
Petrozavodsk, 185019
Nort-Western State Medical Uni /ID# 154376
Saint Petersburg, 191015
Smolensk station JSC Russian R /ID# 167027
Smolensk, 214025
Tula Regional Clinical Hospita /ID# 155539
Tula, 300053
Yaroslavi State Medical Univer /ID# 154383
Yaroslavl, 150000
About this study
Official title: Prospective, Multi-Center, Observational, Program 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
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.
- Keywords
- Adalimumab, Ankylosing spondylitis, Psoriatic arthritis, Spondylarthritis, Humira®
- Medical subject headings
- Spondylarthritis, Arthritis, Psoriatic, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Spondylarthritis | Participants with Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) treated with adalimumab in routine clinical settings in the Russian Federation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants on adalimumab therapy
This is used to assess retention rate. Persistence/Adherence of SpA patient to treatment, as well as retention rate, is an important factor of achieving of treatment goals. Medical non-adherence poses a significant limitation to treating to target in RA and SpA.
Measured: Up to 30 days after administering last dose in the study (52 weeks)
Number of participants on adalimumab therapy
This is used to assess retention rate. Persistence/Adherence of SpA patient to treatment, as well as retention rate, is an important factor of achieving of treatment goals. Medical non-adherence poses a significant limitation to treating to target in rheumatoid arthritis (RA) and SpA.
Measured: Up to 30 days after administering last dose in the study (52 weeks)
Secondary outcomes (4)
Assessing medication persistence
Medication persistence is defined as the duration of time from initiation to discontinuation of therapy.
Measured: Up to 48 weeks of treatment period
Assessing medication adherence
Medication adherence is defined as the extent to which a participant acts in accordance with the prescribed interval and dose of a dosing.
Measured: Up to 48 weeks of treatment period
Change of disease activity in participants with PsA
This is assessed using Disease activity score 28 joints count (DAS28) in participants with PsA.
Measured: Up to 48 weeks of treatment period
Change of disease activity in participants with AS
This is assessed using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with AS.
Measured: Up to 48 weeks of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start22 Dec 2016
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylarthritisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988674
- Sponsor's protocol ID
- P15-672
- Acronym
- Adherence
- Status last verified
- Oct 2020
- First submitted
- 28 Nov 2016
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center, Observational, Program 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
- ClinicalTrials.gov ID
- NCT02988674
- Acronym / sponsor ID
- Adherence / P15-672
- Keywords
- Adalimumab, Ankylosing spondylitis, Psoriatic arthritis, Spondylarthritis, Humira®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Spondylarthritis | – | –Participants with Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) treated with adalimumab in routine clinical settings in the Russian Federation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) participants treated with adalimumab in routine clinical settings in the Russian Federation.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants on adalimumab therapy
Time frame: Up to 30 days after administering last dose in the study (52 weeks)
This is used to assess retention rate. Persistence/Adherence of SpA patient to treatment, as well as retention rate, is an important factor of achieving of treatment goals. Medical non-adherence poses a significant limitation to treating to target in RA and SpA.
Number of participants on adalimumab therapy
Time frame: Up to 30 days after administering last dose in the study (52 weeks)
This is used to assess retention rate. Persistence/Adherence of SpA patient to treatment, as well as retention rate, is an important factor of achieving of treatment goals. Medical non-adherence poses a significant limitation to treating to target in rheumatoid arthritis (RA) and SpA.
4 secondary outcomes
Assessing medication persistence
Time frame: Up to 48 weeks of treatment period
Assessing medication adherence
Time frame: Up to 48 weeks of treatment period
Change of disease activity in participants with PsA
Time frame: Up to 48 weeks of treatment period
Change of disease activity in participants with AS
Time frame: Up to 48 weeks of treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylarthritis and Psoriatic Arthritis, run by AbbVie at 14 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants on adalimumab therapy (time frame: Up to 30 days after administering last dose in the study (52 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.