Clinical trial NCT01163292: Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859 (NCT00870467))
Official title: Humira 40 mg/0.8 mL Syringe for Subcutaneous Injection - Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859)]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-07-15
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study.

Brief summary: The present survey was conducted to evaluate the effectiveness and safety of treatment with adalimumab during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859) in participants who continued treatment with adalimumab for 52 weeks.

Detailed description: This survey was conducted to assess the risk and benefit of continuing or discontinuing biological therapy with adalimumab (Humira) during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859).

Eligibility criteria: Inclusion Criteria:

* The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study and provided informed consent to participate in the present follow-up survey.

Exclusion Criteria:

* Participants who used biological agents other than adalimumab after the period of treatment in the NCT00870467(M06-859) study were excluded from the present follow-up study.

Primary outcomes:
measure: Disease Activity Score (DAS28)
timeFrame: Weeks 0, 26, and 52
Secondary outcomes:
measure: Matrix Metalloprotease-3 (MMP-3)
timeFrame: Weeks 0, 26, and 52
measure: Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52
timeFrame: Week 0 to Week 52
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Weeks 0, 26, and 52
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Week 0 to Week 52
Other outcomes:
Locations:
city: Anjo
country: Japan
facility: Site Reference ID/Investigator# 54680
city: Aomori
country: Japan
facility: Site Reference ID/Investigator# 54677
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 54516
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 54660
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 54683
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 54521
city: Gifu
country: Japan
facility: Site Reference ID/Investigator# 39854
city: Hamamatsu
country: Japan
facility: Site Reference ID/Investigator# 54666
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 54682
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 54669
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 54674
city: Ibaraki
country: Japan
facility: Site Reference ID/Investigator# 54653
city: Kagoshima
country: Japan
facility: Site Reference ID/Investigator# 54670
city: Kagoshima
country: Japan
facility: Site Reference ID/Investigator# 54692
city: Kawagoe
country: Japan
facility: Site Reference ID/Investigator# 54679
city: Kawagoe
country: Japan
facility: Site Reference ID/Investigator# 59580
city: Kawasaki
country: Japan
facility: Site Reference ID/Investigator# 54662
city: Kirishima
country: Japan
facility: Site Reference ID/Investigator# 54693
city: Kitakyushu
country: Japan
facility: Site Reference ID/Investigator# 54671
city: Kumamoto
country: Japan
facility: Site Reference ID/Investigator# 54643
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 59583
city: Maebashi
country: Japan
facility: Site Reference ID/Investigator# 59582
city: Matsumoto
country: Japan
facility: Site Reference ID/Investigator# 39849
city: Matsuyama
country: Japan
facility: Site Reference ID/Investigator# 54520
city: Miyazaki
country: Japan
facility: Site Reference ID/Investigator# 54644
city: Morioka
country: Japan
facility: Site Reference ID/Investigator# 54645
city: Nagano
country: Japan
facility: Site Reference ID/Investigator# 54654
city: Nagaoka
country: Japan
facility: Site Reference ID/Investigator# 54656
city: Nagasaki
country: Japan
facility: Site Reference ID/Investigator# 63052
city: Nagoya
country: Japan
facility: Site Reference ID/Investigator# 54667
city: Nagoya
country: Japan
facility: Site Reference ID/Investigator# 54673
city: Nara
country: Japan
facility: Site Reference ID/Investigator# 54649
city: Niigata
country: Japan
facility: Site Reference ID/Investigator# 39844
city: Oita
country: Japan
facility: Site Reference ID/Investigator# 54675
city: Okayama
country: Japan
facility: Site Reference ID/Investigator# 39847
city: Okayama
country: Japan
facility: Site Reference ID/Investigator# 54681
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 39846
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 54518
city: Rifu
country: Japan
facility: Site Reference ID/Investigator# 54646
city: Sagamihara, Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 54661
city: Saitama
country: Japan
facility: Site Reference ID/Investigator# 54514
city: Saitama
country: Japan
facility: Site Reference ID/Investigator# 54689
city: Sapporo
country: Japan
facility: Site Reference ID/Investigator# 25922
city: Sapporo
country: Japan
facility: Site Reference ID/Investigator# 39850
city: Sapporo
country: Japan
facility: Site Reference ID/Investigator# 54651
city: Sapporo
country: Japan
facility: Site Reference ID/Investigator# 54652
city: Sasebo
country: Japan
facility: Site Reference ID/Investigator# 54522
city: Setouchi
country: Japan
facility: Site Reference ID/Investigator# 54650
city: Shimotsuke
country: Japan
facility: Site Reference ID/Investigator# 39851
city: Shizuoka
country: Japan
facility: Site Reference ID/Investigator# 39845
city: Shizuoka
country: Japan
facility: Site Reference ID/Investigator# 54517
city: Takamatsu
country: Japan
facility: Site Reference ID/Investigator# 59579
city: Takasaki
country: Japan
facility: Site Reference ID/Investigator# 54655
city: Tenri
country: Japan
facility: Site Reference ID/Investigator# 54519
city: Tokorozawa
country: Japan
facility: Site Reference ID/Investigator# 54515
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 39842
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 39852
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 39853
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 54647
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 54657
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 54658
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 54678
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 54688
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 59581
city: Tomigusuku
country: Japan
facility: Site Reference ID/Investigator# 54672
city: Toyama
country: Japan
facility: Site Reference ID/Investigator# 54648
city: Toyama
country: Japan
facility: Site Reference ID/Investigator# 54691
city: Toyoake
country: Japan
facility: Site Reference ID/Investigator# 54690
city: Toyohashi
country: Japan
facility: Site Reference ID/Investigator# 54676
city: Tsu
country: Japan
facility: Site Reference ID/Investigator# 54668
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 39843
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 54663
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 54664
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 54665
city: Yotsukaido
country: Japan
facility: Site Reference ID/Investigator# 54659
Study officials:
affiliation: AbbVie
name: Aki Kuroki
role: STUDY_DIRECTOR
References:
citation: Tanaka Y, Yamanaka H, Ishiguro N, Miyasaka N, Kawana K, Hiramatsu K, Takeuchi T. Adalimumab discontinuation in patients with early rheumatoid arthritis who were initially treated with methotrexate alone or in combination with adalimumab: 1 year outcomes of the HOPEFUL-2 study. RMD Open. 2016 Feb 18;2(1):e000189. doi: 10.1136/rmdopen-2015-000189. eCollection 2016.