Rheumatoid ArthritisNCT01083121

Surveillance of Humira Injection in Korean Patients

An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by AbbVie (prior sponsor, Abbott) at 77 sites in South Korea.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 19 years and older
Conditions the study is for: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
How many people: 1,779 participants
Where: 77 sitesSouth Korea
Study dates: Apr 2007to Jun 2012
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Primary care clinics, general hospitals

Who may be able to join

Adult patients (19 years and above) with one of the following indications:
Moderately to severely active rheumatoid arthritis or
active and progressive psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate or
severe active ankylosing spondylitis who have had an inadequate response to conventional therapy or
severely active Crohn's disease who have had no response, intolerance or contraindication to corticosteroid therapy or immunosuppressants or
moderately to severely active psoriasis patients who have had no response, have intolerance or have contraindication to systemic therapies including cyclosporine, methotrexate or photochemotherapy (PUVA).
Patients who give verbal or written authorization to use their personal and health data.

Who cannot join

Patients with known hypersensitivity to adalimumab or any of its excipients.

Trial locations and contacts

77 sites in 1 country.

City, postcode or hospital

77 sites in 1 country

South Korea77 sites

Site Reference ID/Investigator# 29724
Ansan, 152-703
Site Reference ID/Investigator# 53586
Ansan, 152-703
Site Reference ID/Investigator# 29729
Bucheon-si, 420-767
Site Reference ID/Investigator# 29009
Bucheon-si, 420-818
Site Reference ID/Investigator# 29726
Busan, 602-715
Site Reference ID/Investigator# 29733
Busan, 602-739
Site Reference ID/Investigator# 28582
Busan, 608-838
Site Reference ID/Investigator# 5633
Busan, 611-072
Site Reference ID/Investigator# 28608
Cheonan, 330-715
Site Reference ID/Investigator# 28996
Cheonan, 330-721
Site Reference ID/Investigator# 29735
Daegu, 700-712
Site Reference ID/Investigator# 59287
Daegu, 705-717
Site Reference ID/Investigator# 29278
Daegu, 705-718
Site Reference ID/Investigator# 29279
Daegu, 705-718
Site Reference ID/Investigator# 29007
Daejeon, 301-808
Site Reference ID/Investigator# 29727
Daejeon, 302-799
Site Reference ID/Investigator# 29745
Daejeon, 302-799
Site Reference ID/Investigator# 48624
Daejeon, 302-799
Site Reference ID/Investigator# 29075
Goyang, 411-706
Site Reference ID/Investigator# 29042
Guri-si, 471-701
Site Reference ID/Investigator# 59285
Guri-si, 471-701
Site Reference ID/Investigator# 29731
Gwangju, 501-717
Site Reference ID/Investigator# 81693
Gwangju, 501-717
Site Reference ID/Investigator# 29732
Gwangju, 501-757
Site Reference ID/Investigator# 29737
Gwangju, 501-757
Site Reference ID/Investigator# 29742
Gwangju, 501-757
Site Reference ID/Investigator# 28611
Gyeongju, 780-350
Site Reference ID/Investigator# 29103
Iksan, 570-711
Site Reference ID/Investigator# 29010
Incheon, 403-016
Site Reference ID/Investigator# 28589
Jeju City, 690-766
Site Reference ID/Investigator# 29080
Jeju City, 690-767
Site Reference ID/Investigator# 29743
Jeollabuk-do, 651-180
Site Reference ID/Investigator# 29082
Jeonju, 560-750
Site Reference ID/Investigator# 29740
Jinju, 660-702
Site Reference ID/Investigator# 29172
Masan, 630-522
Site Reference ID/Investigator# 29436
Metropolitan City Daejon, 302-718
Site Reference ID/Investigator# 28970
Pohang, 790-825
Site Reference ID/Investigator# 29723
Seongnam, 463-712
Site Reference ID/Investigator# 29722
Seongnam, 463-824
Site Reference ID/Investigator# 29738
Seoul, 110-744
Site Reference ID/Investigator# 53584
Seoul, 110-744
Site Reference ID/Investigator# 59283
Seoul, 120-752
Site Reference ID/Investigator# 29452
Seoul, 130-702
Site Reference ID/Investigator# 29453
Seoul, 130-702
Site Reference ID/Investigator# 53583
Seoul, 130-702
Site Reference ID/Investigator# 29728
Seoul, 133-792
Site Reference ID/Investigator# 29734
Seoul, 133-792
Site Reference ID/Investigator# 29721
Seoul, 134-709
Site Reference ID/Investigator# 29029
Seoul, 134-727
Site Reference ID/Investigator# 29736
Seoul, 135-710
Site Reference ID/Investigator# 59282
Seoul, 135-710
Site Reference ID/Investigator# 29741
Seoul, 135-720
Site Reference ID/Investigator# 29165
Seoul, 135-895
Site Reference ID/Investigator# 29166
Seoul, 136-705
Site Reference ID/Investigator# 29011
Seoul, 137-701
Site Reference ID/Investigator# 48623
Seoul, 137-701
Site Reference ID/Investigator# 63322
Seoul, 137-701
Site Reference ID/Investigator# 29748
Seoul, 138-736
Site Reference ID/Investigator# 53582
Seoul, 138-736
Site Reference ID/Investigator# 29076
Seoul, 139-707
Site Reference ID/Investigator# 29034
Seoul, 139-872
Site Reference ID/Investigator# 29434
Seoul, 143-729
Site Reference ID/Investigator# 29435
Seoul, 143-729
Site Reference ID/Investigator# 29744
Seoul, 150-030
Site Reference ID/Investigator# 29041
Seoul, 150-071
Site Reference ID/Investigator# 29012
Seoul, 150-713
Site Reference ID/Investigator# 66654
Seoul, 156-707
Site Reference ID/Investigator# 59284
Seoul, 156-755
Site Reference ID/Investigator# 29035
Seoul, 158-710
Site Reference ID/Investigator# 59286
Seoul, 366-144
Site Reference ID/Investigator# 53588
Suwon, 442-723
Site Reference ID/Investigator# 29746
Suwon, 443-721
Site Reference ID/Investigator# 29739
Taegu
Site Reference ID/Investigator# 29085
Uljeongbu, 480-824
Site Reference ID/Investigator# 28610
Ulsan, 681-711
Site Reference ID/Investigator# 29725
Ulsan, 682-714
Site Reference ID/Investigator# 29730
Wŏnju, 220-701

Other trials in South Korea

About this study

Official title: Post-Marketing Surveillance of Humira Injection in Korean Patients Under the "New-Drug Re-examination"

Patients who take Humira as prescribed by physicians as per Korean label will be enrolled and observed in normal medical practice setting for not less than 3 months following first dose of Humira. Information on demographics, diagnosis and medical history, results of tuberculosis skin test, results of chest X-ray, Humira treatment information, concomitant medication, physician's global assessment for effectiveness, disease activity assessment for rheumatoid arthritis, disease activity assessment for Crohn's Disease, disease activity assessment for Psoriasis and adverse events will be recorded on case report forms.

Conditions: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Psoriasis
Keywords: Postmarketing Drug Surveillance
Medical subject headings: Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing, Crohn Disease, Psoriasis

What participants receive

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

Study groups in NCT01083121
Study group	Role	What they receive
Adalimumab		Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.

What is being measured

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

Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.
Measured: From Baseline until up to 70 days after the 3 month study period (total of 160 days).

Secondary outcomes (1)

Physician's Global Assessment for Effectiveness
The investigator's overall assessment for effectiveness was recorded as 'Improved', 'No change', 'Aggravated,' or 'Not assessable'.
Measured: After 3-month treatment

Timeline

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

Apr 2007Jun 2012

First posted9 Mar 2010 (estimated)
Study startApr 2007
Primary completionJun 2012
Study completionJun 2012

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
Observational model: Case only
Time perspective: Prospective
Enrolment: 1,779 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01083121
Sponsor's protocol ID: P10-053
Status last verified: Aug 2013
First submitted: 24 Feb 2010
Last updated: 21 Aug 2013
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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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
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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 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Marketing Surveillance of Humira Injection in Korean Patients Under the "New-Drug Re-examination"
ClinicalTrials.gov ID: NCT01083121
Acronym / sponsor ID: P10-053
Conditions: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Psoriasis
Keywords: Postmarketing Drug Surveillance
Study type: Observational
Recruitment status: Completed
Enrolment: 1,779 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Collaborators: Eisai Co., Ltd.
Study start: Apr 2007
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 9 Mar 2010 (estimated)
Results: Posted 20 Aug 2013

Clinical summary

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

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Adalimumab	–	–Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Primary care clinics, general hospitals

Key inclusion criteria (7 listed)

Adult patients (19 years and above) with one of the following indications:
Patients who give verbal or written authorization to use their personal and health data.

Key exclusion criteria (1 listed)

Patients with known hypersensitivity to adalimumab or any of its excipients.

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

Number of Participants With Adverse Events (AEs)
Time frame: From Baseline until up to 70 days after the 3 month study period (total of 160 days).
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.

1 secondary outcome

Physician's Global Assessment for Effectiveness
Time frame: After 3-month treatment

Results and safety

Results posted to the registry on 20 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adalimumab	1,779	1,698

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: From Baseline until up to 70 days after the 3 month study period (total of 160 days).. Number. Unit: participants

Measure	Adalimumab n = 1698
Any adverse event	171
Any adverse drug reaction	116
Serious adverse events	47
Mild adverse event	115
Moderate adverse event	58
Severe adverse event	7
Discontinued adalimumab due to adverse event	30
Adverse events related to adalimumab	120

Population analysed: Safety analysis population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: For up to 70 days after the 3 month study period (total of 160 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adalimumab	47 of 1,698 (2.8%)	0 of 1,698 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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)
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

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.

Deborah Chee, MD study director

AbbVie Ltd.

77 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 AbbVie (prior sponsor, Abbott) at 77 sites in South Korea.

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 7 inclusion and 1 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 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in South Korea. 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 20 Aug 2013). 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?

Number of Participants With Adverse Events (AEs) (time frame: From Baseline until up to 70 days after the 3 month study period (total of 160 days).). 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 NCT01083121.

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 21 Aug 2013.