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))

Rheumatoid Arthritis Clinical Trial

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)]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163292
• Other study ID #: P12-069
• Status: Completed
• Start date: March 2010
• Est. completion date: October 2012

Study information

• Verified date: December 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Japan	Site Reference ID/Investigator# 54680	Anjo
Japan	Site Reference ID/Investigator# 54677	Aomori
Japan	Site Reference ID/Investigator# 54516	Chiba
Japan	Site Reference ID/Investigator# 54660	Chiba
Japan	Site Reference ID/Investigator# 54683	Chiba
Japan	Site Reference ID/Investigator# 54521	Fukuoka
Japan	Site Reference ID/Investigator# 39854	Gifu
Japan	Site Reference ID/Investigator# 54666	Hamamatsu
Japan	Site Reference ID/Investigator# 54682	Hiroshima
Japan	Site Reference ID/Investigator# 54669	Hyogo
Japan	Site Reference ID/Investigator# 54674	Hyogo
Japan	Site Reference ID/Investigator# 54653	Ibaraki
Japan	Site Reference ID/Investigator# 54670	Kagoshima
Japan	Site Reference ID/Investigator# 54692	Kagoshima
Japan	Site Reference ID/Investigator# 54679	Kawagoe
Japan	Site Reference ID/Investigator# 59580	Kawagoe
Japan	Site Reference ID/Investigator# 54662	Kawasaki
Japan	Site Reference ID/Investigator# 54693	Kirishima
Japan	Site Reference ID/Investigator# 54671	Kitakyushu
Japan	Site Reference ID/Investigator# 54643	Kumamoto
Japan	Site Reference ID/Investigator# 59583	Kyoto
Japan	Site Reference ID/Investigator# 59582	Maebashi
Japan	Site Reference ID/Investigator# 39849	Matsumoto
Japan	Site Reference ID/Investigator# 54520	Matsuyama
Japan	Site Reference ID/Investigator# 54644	Miyazaki
Japan	Site Reference ID/Investigator# 54645	Morioka
Japan	Site Reference ID/Investigator# 54654	Nagano
Japan	Site Reference ID/Investigator# 54656	Nagaoka
Japan	Site Reference ID/Investigator# 63052	Nagasaki
Japan	Site Reference ID/Investigator# 54667	Nagoya
Japan	Site Reference ID/Investigator# 54673	Nagoya
Japan	Site Reference ID/Investigator# 54649	Nara
Japan	Site Reference ID/Investigator# 39844	Niigata
Japan	Site Reference ID/Investigator# 54675	Oita
Japan	Site Reference ID/Investigator# 39847	Okayama
Japan	Site Reference ID/Investigator# 54681	Okayama
Japan	Site Reference ID/Investigator# 39846	Osaka
Japan	Site Reference ID/Investigator# 54518	Osaka
Japan	Site Reference ID/Investigator# 54646	Rifu
Japan	Site Reference ID/Investigator# 54661	Sagamihara, Kanagawa
Japan	Site Reference ID/Investigator# 54514	Saitama
Japan	Site Reference ID/Investigator# 54689	Saitama
Japan	Site Reference ID/Investigator# 25922	Sapporo
Japan	Site Reference ID/Investigator# 39850	Sapporo
Japan	Site Reference ID/Investigator# 54651	Sapporo
Japan	Site Reference ID/Investigator# 54652	Sapporo
Japan	Site Reference ID/Investigator# 54522	Sasebo
Japan	Site Reference ID/Investigator# 54650	Setouchi
Japan	Site Reference ID/Investigator# 39851	Shimotsuke
Japan	Site Reference ID/Investigator# 39845	Shizuoka
Japan	Site Reference ID/Investigator# 54517	Shizuoka
Japan	Site Reference ID/Investigator# 59579	Takamatsu
Japan	Site Reference ID/Investigator# 54655	Takasaki
Japan	Site Reference ID/Investigator# 54519	Tenri
Japan	Site Reference ID/Investigator# 54515	Tokorozawa
Japan	Site Reference ID/Investigator# 39842	Tokyo
Japan	Site Reference ID/Investigator# 39852	Tokyo
Japan	Site Reference ID/Investigator# 39853	Tokyo
Japan	Site Reference ID/Investigator# 54647	Tokyo
Japan	Site Reference ID/Investigator# 54657	Tokyo
Japan	Site Reference ID/Investigator# 54658	Tokyo
Japan	Site Reference ID/Investigator# 54678	Tokyo
Japan	Site Reference ID/Investigator# 54688	Tokyo
Japan	Site Reference ID/Investigator# 59581	Tokyo
Japan	Site Reference ID/Investigator# 54672	Tomigusuku
Japan	Site Reference ID/Investigator# 54648	Toyama
Japan	Site Reference ID/Investigator# 54691	Toyama
Japan	Site Reference ID/Investigator# 54690	Toyoake
Japan	Site Reference ID/Investigator# 54676	Toyohashi
Japan	Site Reference ID/Investigator# 54668	Tsu
Japan	Site Reference ID/Investigator# 39843	Yokohama
Japan	Site Reference ID/Investigator# 54663	Yokohama
Japan	Site Reference ID/Investigator# 54664	Yokohama
Japan	Site Reference ID/Investigator# 54665	Yokohama
Japan	Site Reference ID/Investigator# 54659	Yotsukaido

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Score (DAS28)	The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.	Weeks 0, 26, and 52
Secondary	Matrix Metalloprotease-3 (MMP-3)	MMP-3 level in serum. Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female)	Weeks 0, 26, and 52
Secondary	Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52	Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.	Week 0 to Week 52
Secondary	Health Assessment Questionnaire Disability Index (HAQ-DI)	Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.	Weeks 0, 26, and 52
Secondary	Number of Participants With Adverse Events (AEs)	Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.	Week 0 to Week 52

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