Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis

An observational study of Rheumatoid Arthritis, run by Abbott at 1,723 sites in Japan.

Completed

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

Trial summary

To clarify the following matters: Unknown adverse reactions (especially clinically significant adverse reactions) Incidence and conditions of occurrence of adverse reactions in the clinical setting Factors that may affect the safety and effectiveness of Humira Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Rheumatoid Arthritis
How many people: 7,972 participants
Where: 1,723 sitesJapan
Study dates: Jun 2008to Jun 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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: All patients prescribed and treated with Humira included in this survey.

Who may be able to join

All patients prescribed and treated with Humira are included in this survey.

Who cannot join

Contraindications according to the Package Insert:
Patients who have serious infections,
Patients who have tuberculosis,
Patients with a history of hypersensitivity to any ingredient of Humira,
Patients who have demyelinating disease or with a history of demyelinating disease,
Patients who have cardiac failure congestive.

Trial locations and contacts

1,723 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Japan300 sites

Site Reference ID/Investigator# 35904
Aichi
Site Reference ID/Investigator# 35905
Aichi
Site Reference ID/Investigator# 35906
Aichi
Site Reference ID/Investigator# 35907
Aichi
Site Reference ID/Investigator# 35908
Aichi
Site Reference ID/Investigator# 35909
Aichi
Site Reference ID/Investigator# 35912
Aichi
Site Reference ID/Investigator# 35913
Aichi
Site Reference ID/Investigator# 35914
Aichi
Site Reference ID/Investigator# 35915
Aichi
Site Reference ID/Investigator# 35916
Aichi
Site Reference ID/Investigator# 35917
Aichi
Site Reference ID/Investigator# 35918
Aichi
Site Reference ID/Investigator# 35919
Aichi
Site Reference ID/Investigator# 35920
Aichi
Site Reference ID/Investigator# 35921
Aichi
Site Reference ID/Investigator# 35922
Aichi
Site Reference ID/Investigator# 35923
Aichi
Site Reference ID/Investigator# 35924
Aichi
Site Reference ID/Investigator# 36611
Aichi
Site Reference ID/Investigator# 36644
Aichi
Site Reference ID/Investigator# 36650
Aichi
Site Reference ID/Investigator# 36652
Aichi
Site Reference ID/Investigator# 36676
Aichi
Site Reference ID/Investigator# 36681
Aichi
Site Reference ID/Investigator# 36689
Aichi
Site Reference ID/Investigator# 36696
Aichi
Site Reference ID/Investigator# 36733
Aichi
Site Reference ID/Investigator# 36752
Aichi
Site Reference ID/Investigator# 36819
Aichi
Site Reference ID/Investigator# 36843
Aichi
Site Reference ID/Investigator# 36867
Aichi
Site Reference ID/Investigator# 36923
Aichi
Site Reference ID/Investigator# 36943
Aichi
Site Reference ID/Investigator# 36944
Aichi
Site Reference ID/Investigator# 36945
Aichi
Site Reference ID/Investigator# 39128
Aichi
Site Reference ID/Investigator# 39129
Aichi
Site Reference ID/Investigator# 39130
Aichi
Site Reference ID/Investigator# 39131
Aichi
Site Reference ID/Investigator# 39132
Aichi
Site Reference ID/Investigator# 39133
Aichi
Site Reference ID/Investigator# 39134
Aichi
Site Reference ID/Investigator# 39135
Aichi
Site Reference ID/Investigator# 39136
Aichi
Site Reference ID/Investigator# 39137
Aichi
Site Reference ID/Investigator# 39138
Aichi
Site Reference ID/Investigator# 39140
Aichi
Site Reference ID/Investigator# 39141
Aichi
Site Reference ID/Investigator# 39142
Aichi
Site Reference ID/Investigator# 39143
Aichi
Site Reference ID/Investigator# 39144
Aichi
Site Reference ID/Investigator# 39145
Aichi
Site Reference ID/Investigator# 39146
Aichi
Site Reference ID/Investigator# 39147
Aichi
Site Reference ID/Investigator# 39148
Aichi
Site Reference ID/Investigator# 39149
Aichi
Site Reference ID/Investigator# 39150
Aichi
Site Reference ID/Investigator# 39151
Aichi
Site Reference ID/Investigator# 39152
Aichi
Site Reference ID/Investigator# 39153
Aichi
Site Reference ID/Investigator# 39154
Aichi
Site Reference ID/Investigator# 39155
Aichi
Site Reference ID/Investigator# 39156
Aichi
Site Reference ID/Investigator# 39157
Aichi
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Aichi
Site Reference ID/Investigator# 39159
Aichi
Site Reference ID/Investigator# 39160
Aichi
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Aichi
Site Reference ID/Investigator# 39162
Aichi
Site Reference ID/Investigator# 39163
Aichi
Site Reference ID/Investigator# 39165
Aichi
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Aichi
Site Reference ID/Investigator# 39167
Aichi
Site Reference ID/Investigator# 39168
Aichi
Site Reference ID/Investigator# 42712
Aichi
Site Reference ID/Investigator# 42715
Aichi
Site Reference ID/Investigator# 42723
Aichi
Site Reference ID/Investigator# 42738
Aichi
Site Reference ID/Investigator# 42756
Aichi
Site Reference ID/Investigator# 42757
Aichi
Site Reference ID/Investigator# 42758
Aichi
Site Reference ID/Investigator# 42759
Aichi
Site Reference ID/Investigator# 42760
Aichi
Site Reference ID/Investigator# 42844
Aichi
Site Reference ID/Investigator# 42845
Aichi
Site Reference ID/Investigator# 42846
Aichi
Site Reference ID/Investigator# 42851
Aichi
Site Reference ID/Investigator# 42852
Aichi
Site Reference ID/Investigator# 58587
Aichi
Site Reference ID/Investigator# 58612
Aichi
Site Reference ID/Investigator# 58680
Aichi
Site Reference ID/Investigator# 58681
Aichi
Site Reference ID/Investigator# 58682
Aichi
Site Reference ID/Investigator# 58687
Aichi
Site Reference ID/Investigator# 58838
Aichi
Site Reference ID/Investigator# 58839
Aichi
Site Reference ID/Investigator# 58843
Aichi
Site Reference ID/Investigator# 58844
Aichi
Site Reference ID/Investigator# 58845
Aichi
Site Reference ID/Investigator# 58872
Aichi
Site Reference ID/Investigator# 39508
Aki Takada
Site Reference ID/Investigator# 36549
Akita
Site Reference ID/Investigator# 36796
Akita
Site Reference ID/Investigator# 36948
Akita
Site Reference ID/Investigator# 39169
Akita
Site Reference ID/Investigator# 39170
Akita
Site Reference ID/Investigator# 39171
Akita
Site Reference ID/Investigator# 39172
Akita
Site Reference ID/Investigator# 39173
Akita
Site Reference ID/Investigator# 42717
Akita
Site Reference ID/Investigator# 42871
Akita
Site Reference ID/Investigator# 42872
Akita
Site Reference ID/Investigator# 58820
Akita
Site Reference ID/Investigator# 39865
Amagasaki
Site Reference ID/Investigator# 39866
Amagasaki
Site Reference ID/Investigator# 35925
Aomori
Site Reference ID/Investigator# 35926
Aomori
Site Reference ID/Investigator# 35927
Aomori
Site Reference ID/Investigator# 39176
Aomori
Site Reference ID/Investigator# 39177
Aomori
Site Reference ID/Investigator# 39181
Aomori
Site Reference ID/Investigator# 39182
Aomori
Site Reference ID/Investigator# 39192
Aomori
Site Reference ID/Investigator# 42866
Aomori
Site Reference ID/Investigator# 42867
Aomori
Site Reference ID/Investigator# 42868
Aomori
Site Reference ID/Investigator# 58647
Aomori
Site Reference ID/Investigator# 58819
Aomori
Site Reference ID/Investigator# 36605
Ashiya
Site Reference ID/Investigator# 36082
Chiba
Site Reference ID/Investigator# 36083
Chiba
Site Reference ID/Investigator# 36084
Chiba
Site Reference ID/Investigator# 36085
Chiba
Site Reference ID/Investigator# 36086
Chiba
Site Reference ID/Investigator# 36087
Chiba
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Chiba
Site Reference ID/Investigator# 36089
Chiba
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Chiba
Site Reference ID/Investigator# 36091
Chiba
Site Reference ID/Investigator# 36449
Chiba
Site Reference ID/Investigator# 36455
Chiba
Site Reference ID/Investigator# 36600
Chiba
Site Reference ID/Investigator# 36610
Chiba
Site Reference ID/Investigator# 36693
Chiba
Site Reference ID/Investigator# 36694
Chiba
Site Reference ID/Investigator# 36808
Chiba
Site Reference ID/Investigator# 36817
Chiba
Site Reference ID/Investigator# 36830
Chiba
Site Reference ID/Investigator# 38528
Chiba
Site Reference ID/Investigator# 39193
Chiba
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Chiba
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Chiba
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Chiba
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Chiba
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Chiba
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Chiba
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Chiba
Site Reference ID/Investigator# 39209
Chiba
Site Reference ID/Investigator# 39210
Chiba
Site Reference ID/Investigator# 39211
Chiba
Site Reference ID/Investigator# 39212
Chiba
Site Reference ID/Investigator# 39213
Chiba
Site Reference ID/Investigator# 39214
Chiba
Site Reference ID/Investigator# 39215
Chiba
Site Reference ID/Investigator# 39216
Chiba
Site Reference ID/Investigator# 39217
Chiba
Site Reference ID/Investigator# 39221
Chiba
Site Reference ID/Investigator# 39224
Chiba
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Chiba
Site Reference ID/Investigator# 39226
Chiba
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Chiba
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Chiba
Site Reference ID/Investigator# 42761
Chiba
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Chiba
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Chiba
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Chiba
Site Reference ID/Investigator# 42832
Chiba
Site Reference ID/Investigator# 42833
Chiba
Site Reference ID/Investigator# 58668
Chiba
Site Reference ID/Investigator# 58676
Chiba
Site Reference ID/Investigator# 58831
Chiba
Site Reference ID/Investigator# 39964
Chūō
Site Reference ID/Investigator# 39965
Chūō
Site Reference ID/Investigator# 42725
Daisuke
Site Reference ID/Investigator# 36092
Ehime
Site Reference ID/Investigator# 36093
Ehime
Site Reference ID/Investigator# 36903
Ehime
Site Reference ID/Investigator# 39229
Ehime
Site Reference ID/Investigator# 39230
Ehime
Site Reference ID/Investigator# 39231
Ehime
Site Reference ID/Investigator# 39234
Ehime
Site Reference ID/Investigator# 39235
Ehime
Site Reference ID/Investigator# 39239
Ehime
Site Reference ID/Investigator# 39240
Ehime
Site Reference ID/Investigator# 39241
Ehime
Site Reference ID/Investigator# 42740
Ehime
Site Reference ID/Investigator# 42815
Ehime
Site Reference ID/Investigator# 58592
Ehime
Site Reference ID/Investigator# 58601
Ehime
Site Reference ID/Investigator# 58778
Ehime
Site Reference ID/Investigator# 58779
Ehime
Site Reference ID/Investigator# 39910
Fuchū
Site Reference ID/Investigator# 42825
Fujisawa
Site Reference ID/Investigator# 36094
Fukui
Site Reference ID/Investigator# 36095
Fukui
Site Reference ID/Investigator# 36096
Fukui
Site Reference ID/Investigator# 36097
Fukui
Site Reference ID/Investigator# 36548
Fukui
Site Reference ID/Investigator# 36571
Fukui
Site Reference ID/Investigator# 36742
Fukui
Site Reference ID/Investigator# 36911
Fukui
Site Reference ID/Investigator# 39246
Fukui
Site Reference ID/Investigator# 39247
Fukui
Site Reference ID/Investigator# 39248
Fukui
Site Reference ID/Investigator# 39252
Fukui
Site Reference ID/Investigator# 39253
Fukui
Site Reference ID/Investigator# 39254
Fukui
Site Reference ID/Investigator# 39255
Fukui
Site Reference ID/Investigator# 39256
Fukui
Site Reference ID/Investigator# 42762
Fukui
Site Reference ID/Investigator# 42924
Fukui
Site Reference ID/Investigator# 58595
Fukui
Site Reference ID/Investigator# 58611
Fukui
Site Reference ID/Investigator# 58706
Fukui
Site Reference ID/Investigator# 36099
Fukuoka
Site Reference ID/Investigator# 36100
Fukuoka
Site Reference ID/Investigator# 36101
Fukuoka
Site Reference ID/Investigator# 36102
Fukuoka
Site Reference ID/Investigator# 36103
Fukuoka
Site Reference ID/Investigator# 36104
Fukuoka
Site Reference ID/Investigator# 36105
Fukuoka
Site Reference ID/Investigator# 36106
Fukuoka
Site Reference ID/Investigator# 36107
Fukuoka
Site Reference ID/Investigator# 36108
Fukuoka
Site Reference ID/Investigator# 36109
Fukuoka
Site Reference ID/Investigator# 36110
Fukuoka
Site Reference ID/Investigator# 36111
Fukuoka
Site Reference ID/Investigator# 36112
Fukuoka
Site Reference ID/Investigator# 36113
Fukuoka
Site Reference ID/Investigator# 36114
Fukuoka
Site Reference ID/Investigator# 36115
Fukuoka
Site Reference ID/Investigator# 36116
Fukuoka
Site Reference ID/Investigator# 36118
Fukuoka
Site Reference ID/Investigator# 36120
Fukuoka
Site Reference ID/Investigator# 36121
Fukuoka
Site Reference ID/Investigator# 36122
Fukuoka
Site Reference ID/Investigator# 36445
Fukuoka
Site Reference ID/Investigator# 36544
Fukuoka
Site Reference ID/Investigator# 36568
Fukuoka
Site Reference ID/Investigator# 36597
Fukuoka
Site Reference ID/Investigator# 36601
Fukuoka
Site Reference ID/Investigator# 36606
Fukuoka
Site Reference ID/Investigator# 36642
Fukuoka
Site Reference ID/Investigator# 36645
Fukuoka
Site Reference ID/Investigator# 36651
Fukuoka
Site Reference ID/Investigator# 36660
Fukuoka
Site Reference ID/Investigator# 36670
Fukuoka
Site Reference ID/Investigator# 36692
Fukuoka
Site Reference ID/Investigator# 36699
Fukuoka
Site Reference ID/Investigator# 36748
Fukuoka
Site Reference ID/Investigator# 36799
Fukuoka
Site Reference ID/Investigator# 36801
Fukuoka
Site Reference ID/Investigator# 36870
Fukuoka
Site Reference ID/Investigator# 36907
Fukuoka
Site Reference ID/Investigator# 36910
Fukuoka
Site Reference ID/Investigator# 36914
Fukuoka
Site Reference ID/Investigator# 39174
Fukuoka
Site Reference ID/Investigator# 39175
Fukuoka
Site Reference ID/Investigator# 39178
Fukuoka
Site Reference ID/Investigator# 39179
Fukuoka
Site Reference ID/Investigator# 39183
Fukuoka
Site Reference ID/Investigator# 39184
Fukuoka
Site Reference ID/Investigator# 39185
Fukuoka
Site Reference ID/Investigator# 39186
Fukuoka
Site Reference ID/Investigator# 39187
Fukuoka
Site Reference ID/Investigator# 39188
Fukuoka
Site Reference ID/Investigator# 39189
Fukuoka
Site Reference ID/Investigator# 39190
Fukuoka
Site Reference ID/Investigator# 39191
Fukuoka
Site Reference ID/Investigator# 39201
Fukuoka
Site Reference ID/Investigator# 39202
Fukuoka
Site Reference ID/Investigator# 39203
Fukuoka
Site Reference ID/Investigator# 39204
Fukuoka
Site Reference ID/Investigator# 39205
Fukuoka
Site Reference ID/Investigator# 39206
Fukuoka
Site Reference ID/Investigator# 39207
Fukuoka
Site Reference ID/Investigator# 39208
Fukuoka
Site Reference ID/Investigator# 39218
Fukuoka
Site Reference ID/Investigator# 39219
Fukuoka
Site Reference ID/Investigator# 39220
Fukuoka
Site Reference ID/Investigator# 39222
Fukuoka
Site Reference ID/Investigator# 39232
Fukuoka
Site Reference ID/Investigator# 39233
Fukuoka
Site Reference ID/Investigator# 42711
Fukuoka
Site Reference ID/Investigator# 42763
Fukuoka
Site Reference ID/Investigator# 42764
Fukuoka
Site Reference ID/Investigator# 42805
Fukuoka
Site Reference ID/Investigator# 58580
Fukuoka
Site Reference ID/Investigator# 58782
Fukuoka

Other trials in Japan

About this study

Official title: Humira 40 mg/0.8 mL for Subcutaneous Injection - Drug Use Investigation (All Patient Investigation) for Rheumatoid Arthritis

To clarify the following matters:

Unknown adverse reactions (especially clinically significant adverse reactions)
Incidence and conditions of occurrence of adverse reactions in the clinical setting
Factors that may affect the safety and effectiveness of Humira

Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

Study groups in NCT01076959
Study group	Role	What they receive
Humira		The sponsor was required to include all patients diagnosed with rheumatoid arthritis and who were treated Humira in routine medical practice during the review period by the PMDA. The safety analysis set included all patients who met all eligibility criteria and received at least one dose of Humira. The full analysis set included all patients who were treated with Humira for at least 2 weeks and had complete DAS 28 assessments at baseline and at least one other time point.

What is being measured

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

Total Number of Patients With Adverse Events
Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.
Measured: Baseline to Week 24
Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Measured: Week 4
Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Measured: Week 12
Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Measured: Week 24

Secondary outcomes (1)

Physicians' Overall Effectiveness Response Rating
Physicians' rated the level of overall patient improvement as "markedly improved," "improved," "not changed," or "not assessable" by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions.
Measured: Week 24

Timeline

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

Jun 2008Jun 2011

First posted26 Feb 2010 (estimated)
Study startJun 2008
Primary completionJun 2011
Study completionJun 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.
Publications (2)Papers the sponsor has linked to this study.
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: Cohort
Time perspective: Prospective
Enrolment: 7,972 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01076959
Sponsor's protocol ID: P10-559
Status last verified: Aug 2012
First submitted: 25 Feb 2010
Last updated: 28 Aug 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, Yamanaka H, Takasaki Y, Mimori T, Hiramatsu K, Komatsu S, Tanaka Y. Effect of Methotrexate Plus Adalimumab on the Achievement of Rheumatoid Arthritis Therapeutic Goals: Post Hoc Analysis of Japanese Patients (MELODY Study). Rheumatol Ther. 2016 Jun;3(1):129-141. doi: 10.1007/s40744-015-0023-x. Epub 2015 Dec 22.
PubMed 27747511
Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, Yamanaka H, Haruna S, Ushida N, Kawana K, Tanaka Y. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of 7740 patients. Mod Rheumatol. 2014 May;24(3):390-8. doi: 10.3109/14397595.2013.843760. Epub 2013 Nov 6.
PubMed 24252049

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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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Humira 40 mg/0.8 mL for Subcutaneous Injection - Drug Use Investigation (All Patient Investigation) for Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT01076959
Acronym / sponsor ID: P10-559
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 7,972 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 26 Feb 2010 (estimated)
Results: Posted 7 Aug 2012

Clinical summary

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

To clarify the following matters:

Unknown adverse reactions (especially clinically significant adverse reactions)
Incidence and conditions of occurrence of adverse reactions in the clinical setting
Factors that may affect the safety and effectiveness of Humira

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Humira	–	–The sponsor was required to include all patients diagnosed with rheumatoid arthritis and who were treated Humira in routine medical practice during the review period by the PMDA. The safety analysis set included all patients who met all eligibility criteria and received at least one dose of Humira. The full analysis set included all patients who were treated with Humira for at least 2 weeks and had complete DAS 28 assessments at baseline and at least one other time point.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All patients prescribed and treated with Humira included in this survey.

Key inclusion criteria (1 listed)

All patients prescribed and treated with Humira are included in this survey.

Key exclusion criteria (6 listed)

Contraindications according to the Package Insert:

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

Total Number of Patients With Adverse Events
Time frame: Baseline to Week 24
Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.
Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4
Time frame: Week 4
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12
Time frame: Week 12
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24
Time frame: Week 24
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).

1 secondary outcome

Physicians' Overall Effectiveness Response Rating
Time frame: Week 24

Results and safety

Results posted to the registry on 7 Aug 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
Humira	7,740	5,490

Primary outcome: Total Number of Patients With Adverse Events

Time frame: Baseline to Week 24. Number. Unit: Percentage of Patients

Measure	Humira n = 7740
Value	27.8

Population analysed: The safety population included all patients who received at least one dose of Humira, had one set of case report forms, and were registered with PMDA during the review period.

Primary outcome: Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4

Time frame: Week 4. Number. Unit: Percentage of patients

Measure	Humira - Good Response n = 3341	Humira - Moderate Response n = 3341	Humira - No Response n = 3341	Effective Rate-Sum of Patients With Good or Moderate Response n = 3341
Value	20.4	45.7	33.9	66.1

Population analysed: Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.

Primary outcome: Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12

Time frame: Week 12. Number. Unit: percentage of patients

Measure	Humira - Good Response n = 3927	Humira - Moderate Response n = 3927	Humira - No Response n = 3927	Effective Rate-Sum of Patients With Good or Moderate Response n = 3927
Value	26.4	42.6	31.1	68.9

Primary outcome: Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24

Time frame: Week 24. Number. Unit: Percentage of Patients

Measure	Humira - Good Response n = 4410	Humira - Moderate Response n = 4410	Humira - No Response n = 4410	Effective Rate-Sum of Patients With Good and Moderate Response n = 4410
Value	30.7	39.3	29.9	70.1

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Humira	469 of 7,740 (6.1%)	863 of 7,740 (11.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27747511Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, Yamanaka H, Takasaki Y, Mimori T, Hiramatsu K, Komatsu S, Tanaka Y. Effect of Methotrexate Plus Adalimumab on the Achievement of Rheumatoid Arthritis Therapeutic Goals: Post Hoc Analysis of Japanese Patients (MELODY Study). Rheumatol Ther. 2016 Jun;3(1):129-141. doi: 10.1007/s40744-015-0023-x. Epub 2015 Dec 22.
Derived from this study: PubMed 24252049Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, Yamanaka H, Haruna S, Ushida N, Kawana K, Tanaka Y. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of 7740 patients. Mod Rheumatol. 2014 May;24(3):390-8. doi: 10.3109/14397595.2013.843760. Epub 2013 Nov 6.

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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.

Toshiro Maeda study director

Abbott Japan Co.,Ltd

1,723 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, run by Abbott at 1,723 sites in Japan.

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 1 inclusion and 6 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 28 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,723 sites in Japan. 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 7 Aug 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?

Total Number of Patients With Adverse Events (time frame: Baseline to Week 24). The study lists 4 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 NCT01076959, which also lists 2 linked publications.

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 28 Aug 2012.