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))

NCT01163292 | Completed Results

• 1 other identifier: P12-069
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 75

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Matrix Metalloprotease-3 (MMP-3)

  Weeks 0, 26, and 52

• Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52

  Week 0 to Week 52

• Health Assessment Questionnaire Disability Index (HAQ-DI)

  Weeks 0, 26, and 52

• Number of Participants With Adverse Events (AEs)

  Week 0 to Week 52

Study Arms (2)

Adalimumab

Participants who continued adalimumab treatment after completion of Study NCT00870467 (M06-859)

Non-Adalimumab

Participants who discontinued adalimumab treatment after completion of Study NCT00870467(M06-859)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (75)

Site Reference ID/Investigator# 54680

Anjo, Japan

Location

Site Reference ID/Investigator# 54677

Aomori, Japan

Location

Site Reference ID/Investigator# 54516

Chiba, Japan

Location

Site Reference ID/Investigator# 54660

Chiba, Japan

Location

Site Reference ID/Investigator# 54683

Chiba, Japan

Location

Site Reference ID/Investigator# 54521

Fukuoka, Japan

Location

Site Reference ID/Investigator# 39854

Gifu, Japan

Location

Site Reference ID/Investigator# 54666

Hamamatsu, Japan

Location

Site Reference ID/Investigator# 54682

Hiroshima, Japan

Location

Site Reference ID/Investigator# 54669

Hyōgo, Japan

Location

Site Reference ID/Investigator# 54674

Hyōgo, Japan

Location

Site Reference ID/Investigator# 54653

Ibaraki, Japan

Location

Site Reference ID/Investigator# 54670

Kagoshima, Japan

Location

Site Reference ID/Investigator# 54692

Kagoshima, Japan

Location

Site Reference ID/Investigator# 54679

Kawagoe, Japan

Location

Site Reference ID/Investigator# 59580

Kawagoe, Japan

Location

Site Reference ID/Investigator# 54662

Kawasaki, Japan

Location

Site Reference ID/Investigator# 54693

Kirishima, Japan

Location

Site Reference ID/Investigator# 54671

Kitakyushu, Japan

Location

Site Reference ID/Investigator# 54643

Kumamoto, Japan

Location

Site Reference ID/Investigator# 59583

Kyoto, Japan

Location

Site Reference ID/Investigator# 59582

Maebashi, Japan

Location

Site Reference ID/Investigator# 39849

Matsumoto, Japan

Location

Site Reference ID/Investigator# 54520

Matsuyama, Japan

Location

Site Reference ID/Investigator# 54644

Miyazaki, Japan

Location

Site Reference ID/Investigator# 54645

Morioka, Japan

Location

Site Reference ID/Investigator# 54654

Nagano, Japan

Location

Site Reference ID/Investigator# 54656

Nagaoka, Japan

Location

Site Reference ID/Investigator# 63052

Nagasaki, Japan

Location

Site Reference ID/Investigator# 54667

Nagoya, Japan

Location

Site Reference ID/Investigator# 54673

Nagoya, Japan

Location

Site Reference ID/Investigator# 54649

Nara, Japan

Location

Site Reference ID/Investigator# 39844

Niigata, Japan

Location

Site Reference ID/Investigator# 39847

Okayama, Japan

Location

Site Reference ID/Investigator# 54681

Okayama, Japan

Location

Site Reference ID/Investigator# 39846

Osaka, Japan

Location

Site Reference ID/Investigator# 54518

Osaka, Japan

Location

Site Reference ID/Investigator# 54675

Ōita, Japan

Location

Site Reference ID/Investigator# 54646

Rifu, Japan

Location

Site Reference ID/Investigator# 54661

Sagamihara, Kanagawa, Japan

Location

Site Reference ID/Investigator# 54514

Saitama, Japan

Location

Site Reference ID/Investigator# 54689

Saitama, Japan

Location

Site Reference ID/Investigator# 25922

Sapporo, Japan

Location

Site Reference ID/Investigator# 39850

Sapporo, Japan

Location

Site Reference ID/Investigator# 54651

Sapporo, Japan

Location

Site Reference ID/Investigator# 54652

Sapporo, Japan

Location

Site Reference ID/Investigator# 54522

Sasebo, Japan

Location

Site Reference ID/Investigator# 54650

Setouchi, Japan

Location

Site Reference ID/Investigator# 39851

Shimotsuke, Japan

Location

Site Reference ID/Investigator# 39845

Shizuoka, Japan

Location

Site Reference ID/Investigator# 54517

Shizuoka, Japan

Location

Site Reference ID/Investigator# 59579

Takamatsu, Japan

Location

Site Reference ID/Investigator# 54655

Takasaki, Japan

Location

Site Reference ID/Investigator# 54519

Tenri, Japan

Location

Site Reference ID/Investigator# 54515

Tokorozawa, Japan

Location

Site Reference ID/Investigator# 39842

Tokyo, Japan

Location

Site Reference ID/Investigator# 39852

Tokyo, Japan

Location

Site Reference ID/Investigator# 39853

Tokyo, Japan

Location

Site Reference ID/Investigator# 54647

Tokyo, Japan

Location

Site Reference ID/Investigator# 54657

Tokyo, Japan

Location

Site Reference ID/Investigator# 54658

Tokyo, Japan

Location

Site Reference ID/Investigator# 54678

Tokyo, Japan

Location

Site Reference ID/Investigator# 54688

Tokyo, Japan

Location

Site Reference ID/Investigator# 59581

Tokyo, Japan

Location

Site Reference ID/Investigator# 54672

Tomigusuku, Japan

Location

Site Reference ID/Investigator# 54648

Toyama, Japan

Location

Site Reference ID/Investigator# 54691

Toyama, Japan

Location

Site Reference ID/Investigator# 54690

Toyoake, Japan

Location

Site Reference ID/Investigator# 54676

Toyohashi, Japan

Location

Site Reference ID/Investigator# 54668

Tsu, Japan

Location

Site Reference ID/Investigator# 39843

Yokohama, Japan

Location

Site Reference ID/Investigator# 54663

Yokohama, Japan

Location

Site Reference ID/Investigator# 54664

Yokohama, Japan

Location

Site Reference ID/Investigator# 54665

Yokohama, Japan

Location

Site Reference ID/Investigator# 54659

Yotsukaidō, Japan

Location

Related Publications (1)

• 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.

  PMID: 26925252 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Aki Kuroki

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 15, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 6, 2018
• Results First Posted: December 11, 2013

Record last verified: 2013-12

Locations

JP (75)