Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed Adalimumab (Humira®) as Part of Routine Clinical Care

An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Abbott at 43 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this post-marketing observational study was to obtain data on the characteristics (patient age/gender; disease type, severity and duration; disease specific treatment history; current concomitant medications; other relevant medical history) of patients prescribed adalimumab (Humira®) for… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
How many people: 252 participants
Where: 43 sitesRussia
Study dates: Jan 2008to Nov 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis prescribed adalimumab as part of Routine Clinical Care in Russia.

Who may be able to join

Patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria:
Patients who are newly prescribed adalimumab therapy (no prior history of treatment with adalimumab) including patients with infliximab treatment history.
Patients who completed Abbott sponsored interventional trials and are continuing treatment with commercial adalimumab thereafter.

Who cannot join

The following patients will not be included in the study:
Patients who are being treated or will be treated with drugs at risk of interactions with adalimumab.
Hypersensitivity to adalimumab
Pregnancy
Lactation
Age below 18
Infectious diseases including tuberculosis
Patients currently participating in another clinical trial.

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

Russia43 sites

Site Ref # / Investigator 50728
Belgorod, 308007
Site Ref # / Investigator 50737
Chelyabinsk, 454047
Site Ref # / Investigator 50731
Izhevsk, 426009
Site Reference ID/Investigator# 29084
Kaliningrad, 236000
Site Reference ID/Investigator# 29163
Khanty-Mansiysk, 626200
Site Ref # / Investigator 50746
Khanty-Mansiysk, 628600
Site Ref # / Investigator 50736
Krasnogorsk, 143420
Site Ref # / Investigator 50727
Lipetsk, 308036
Site Ref # / Investigator 50723
Moscow, 105203
Site Ref # / Investigator 50725
Moscow, 105229
Site Ref # / Investigator 50742
Moscow, 109451
Site Ref # / Investigator 50743
Moscow, 109451
Site Ref # / Investigator 50724
Moscow, 115682
Site Ref # / Investigator 50739
Moscow, 121356
Site Ref # / Investigator 50732
Moscow, 123060
Site Ref # / Investigator 50738
Moscow, 123098
Site Ref # / Investigator 50744
Moscow, 123308
Site Reference ID/Investigator# 28989
Moscow, 125009
Site Reference ID/Investigator# 28990
Moscow, 125009
Site Reference ID/Investigator# 29195
Moscow, 125009
Site Reference ID/Investigator# 29482
Moscow, 125009
Site Reference ID/Investigator# 29483
Moscow, 125009
Site Ref # / Investigator 50740
Moscow, 127206
Site Ref # / Investigator 50733
Moscow, 127473
Site Ref # / Investigator 50745
Moscow, 127543
Site Ref # / Investigator 50741
Moscow, 127642
Site Reference ID/Investigator# 28956
Nizhnevartovsk, 628600
Site Reference ID/Investigator# 28968
Perm, 614014
Site Reference ID/Investigator# 28969
Perm, 614014
Site Reference ID/Investigator# 28957
Saint Petersburg, 190000
Site Reference ID/Investigator# 28997
Saint Petersburg, 190000
Site Reference ID/Investigator# 28999
Saint Petersburg, 190000
Site Reference ID/Investigator# 29001
Saint Petersburg, 190000
Site Reference ID/Investigator# 32403
Saint Petersburg, 191015
Site Ref # / Investigator 50729
Salekhard, 629001
Site Reference ID/Investigator# 29008
Surgut, 628400
Site Reference ID/Investigator# 32404
Tula, 300036
Site Reference ID/Investigator# 29095
Ulyanovsk, 432000
Site Ref # / Investigator 50734
V. Novgorod, 173008
Site Ref # / Investigator 50730
Vologda, 160001
Site Ref # / Investigator 50735
Voronezh, 394024
Site Ref # / Investigator 50726
Voronezh, 394082
Site Reference ID/Investigator# 6002
Yekaterinburg, 620000

Other trials in Russia

About this study

Official title: A Multi-Center Post Marketing Observational Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed HUMIRA® (Adalimumab) as Part of Routine Clinical Care in Russia

Read the detailed description

This is a non-interventional, observational study in which adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exist that characterize patient types and adalimumab administration within the Russian population. Further, it is important to characterize the compliance, acceptability of patient self-injection, tolerability and safety profile of this therapy option with the routine clinical care.

The total follow-up for each participant was planned to be 12 months, with approximately 6 follow-up visits occurring at average intervals of 2-3 months. However, since this was an observational study, follow-up was performed according to routine clinical practice; for 127 participants the follow-up period consisted of more than 12 months and the maximum observation period lasted 18.2 months. Follow-up visits were designated sequential visit numbers (Visit 1-6), regardless of the time point at which they occurred.

Conditions: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
Keywords: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
Medical subject headings: Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01163916
Study group	Role	What they receive
Patients with RA, PsA and AS		Patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) prescribed adalimumab as part of Routine Clinical Care in Russia.

What is being measured

The primary outcome is the main question the study is designed to answer.

Characteristics of Patients Prescribed Adalimumab: Education Level
Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.
Measured: Baseline
Characteristics of Patients Prescribed Adalimumab: Occupation
Participants were asked to indicate their occupation at the Baseline visit.
Measured: Baseline
Characteristics of Patients Prescribed Adalimumab: Residence Status
Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.
Measured: Baseline
Characteristics of Patients Prescribed Adalimumab: Marital Status
Participants were asked to indicate their marital status at the Baseline visit.
Measured: Baseline
Characteristics of Patients Prescribed Adalimumab: Disease Severity
Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.
Measured: Baseline
Characteristics of Patients Prescribed Adalimumab: Duration of Disease
Duration of disease was defined as the time from diagnosis until study entry.
Measured: Baseline
Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment
Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented.
Measured: Baseline and at each follow-up visit (up to a maximum of 18.2 months).

Secondary outcomes (3)

Patient's Acceptability of Self-injections
At each clinic visit participants were asked to rate the convenience of adalimumab injections. Possible options were "convenient," "inconvenient" and "unable to self-inject."
The study follow-up period consisted of approximately 6 follow-up visits occurring at average intervals of 2-3 months, according to routine clinical practice.
Acceptability data are reported by follow-up visit and by treatment regimen: 40 mg every other week or 40 mg once a week, as prescribed in accordance with local marketing authorization.
Measured: Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.
Percentage of Participants With Missed or Delayed Injections
Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days.
Measured: For the duration of the study (up to a maximum of 18.2 months).
Duration of Treatment With Adalimumab
Tolerability to adalimumab treatment was analyzed by the time on treatment until development of an adverse event leading to adalimumab discontinuation or until discontinuation from treatment for any other reason.
Measured: For the duration of the study (up to a maximum of 18.2 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Nov 2011

First posted16 Jul 2010 (estimated)
Study startJan 2008
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
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
Time perspective: Prospective
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01163916
Sponsor's protocol ID: P10-272
Status last verified: Dec 2012
First submitted: 26 Feb 2010
Last updated: 7 Dec 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center Post Marketing Observational Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed HUMIRA® (Adalimumab) as Part of Routine Clinical Care in Russia
ClinicalTrials.gov ID: NCT01163916
Acronym / sponsor ID: P10-272
Conditions: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
Keywords: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
Study type: Observational
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Scientific Research Institute of Rheumatology, Moscow, Almedis
Study start: Jan 2008
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 16 Jul 2010 (estimated)
Results: Posted 5 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with RA, PsA and AS	–	–Patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) prescribed adalimumab as part of Routine Clinical Care in Russia.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis prescribed adalimumab as part of Routine Clinical Care in Russia.

Key inclusion criteria (3 listed)

Patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria:
Patients who are newly prescribed adalimumab therapy (no prior history of treatment with adalimumab) including patients with infliximab treatment history.
Patients who completed Abbott sponsored interventional trials and are continuing treatment with commercial adalimumab thereafter.

Key exclusion criteria (8 listed)

Patients who are being treated or will be treated with drugs at risk of interactions with adalimumab.
Hypersensitivity to adalimumab
Pregnancy
Lactation
Age below 18

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

Characteristics of Patients Prescribed Adalimumab: Education Level
Time frame: Baseline
Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.
Characteristics of Patients Prescribed Adalimumab: Occupation
Time frame: Baseline
Participants were asked to indicate their occupation at the Baseline visit.
Characteristics of Patients Prescribed Adalimumab: Residence Status
Time frame: Baseline
Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.
Characteristics of Patients Prescribed Adalimumab: Marital Status
Time frame: Baseline
Participants were asked to indicate their marital status at the Baseline visit.
Characteristics of Patients Prescribed Adalimumab: Disease Severity
Time frame: Baseline
Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.
Characteristics of Patients Prescribed Adalimumab: Duration of Disease
Time frame: Baseline
Duration of disease was defined as the time from diagnosis until study entry.
Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment
Time frame: Baseline and at each follow-up visit (up to a maximum of 18.2 months).
Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented.

3 secondary outcomes

Patient's Acceptability of Self-injections
Time frame: Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.
Percentage of Participants With Missed or Delayed Injections
Time frame: For the duration of the study (up to a maximum of 18.2 months).
Duration of Treatment With Adalimumab
Time frame: For the duration of the study (up to a maximum of 18.2 months).

Results and safety

Results posted to the registry on 5 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rheumatoid Arthritis	126	96
Psoriatic Arthritis	35	31
Ankylosing Spondylitis	91	71

Primary outcome: Characteristics of Patients Prescribed Adalimumab: Education Level

Time frame: Baseline. Number. Unit: participants

Measure	Rheumatoid Arthritis n = 126	Psoriatic Arthritis n = 35	Ankylosing Spondylitis n = 91
Secondary school	21	2	5
Vocational school/college	34	9	26
University degree	64	19	51
Current university student	5	5	8
Other	2	0	1

Primary outcome: Characteristics of Patients Prescribed Adalimumab: Occupation

Time frame: Baseline. Number. Unit: participants

Measure	Rheumatoid Arthritis n = 126	Psoriatic Arthritis n = 35	Ankylosing Spondylitis n = 91
Blue collar worker	13	5	10
Civil servant	10	5	12
White collar worker	52	13	38
Self-employed	8	1	9
Student	7	4	4
Retired	21	4	4
Other	15	3	14

Primary outcome: Characteristics of Patients Prescribed Adalimumab: Residence Status

Time frame: Baseline. Number. Unit: participants

Measure	Rheumatoid Arthritis n = 126	Psoriatic Arthritis n = 35	Ankylosing Spondylitis n = 91
Permanent	113	33	88
Temporary	13	2	3

Primary outcome: Characteristics of Patients Prescribed Adalimumab: Marital Status

Time frame: Baseline. Number. Unit: participants

Measure	Rheumatoid Arthritis n = 126	Psoriatic Arthritis n = 35	Ankylosing Spondylitis n = 91
Married	94	24	69
Single	32	11	21
Missing	0	0	1

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rheumatoid Arthritis	2 of 125 (1.6%)	9 of 125 (7.2%)	Not reported
Psoriatic Arthritis	0 of 35 (0%)	0 of 35 (0%)	Not reported
Ankylosing Spondylitis	0 of 91 (0%)	8 of 91 (8.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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.

Andrey N Strugovschikov, MD study director

Abbott Russia

43 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Abbott at 43 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 3 inclusion and 8 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 7 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 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?

Yes. Results are posted in the registry (first posted 5 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Characteristics of Patients Prescribed Adalimumab: Education Level (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01163916.

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 7 Dec 2012.