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A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

NCT ID: NCT00870467

Last Updated: 2012-08-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-08-31

Brief Summary

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To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.

Detailed Description

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This was a Phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo in adult Japanese patients with early rheumatoid arthritis (RA) who had not been previously treated with methotrexate (MTX). Eligible participants were randomized 1:1 to receive either a subcutaneous injection of adalimumab 40 mg or matching placebo every other week (eow) during the 26-week double-blind phase. All participants also received 6 mg to 8 mg MTX weekly as basal treatment for their disease. Participants who experienced an increase in disease activity (more than 20% increase in tender joint count and swollen joint count) at Week 12, 16, or 20 compared with Baseline after having increased MTX dose to 8 mg per week for at least 4 weeks were discontinued from the double-blind phase and were eligible to receive open-label adalimumab 40 mg eow as rescue treatment. Participants who completed the 26 weeks of treatment (either double-blind study drug \[adalimumab or placebo\] treatment or open-label adalimumab treatment) were eligible to enter the 26-week open-label phase in which they received adalimumab 40 mg eow. Efficacy and safety assessments were performed at Baseline and at designated study visits.

Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DB Placebo

Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.

Group Type PLACEBO_COMPARATOR

Double-blind Placebo

Intervention Type DRUG

Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)

DB adalimumab

Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.

Group Type EXPERIMENTAL

Double-blind adalimumab

Intervention Type BIOLOGICAL

Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)

DB Adalimumab/OL Adalimumab

Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.

Group Type EXPERIMENTAL

Double-blind adalimumab

Intervention Type BIOLOGICAL

Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)

Open-label Adalimumab

Intervention Type BIOLOGICAL

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study

DB Placebo/OL Adalimumab

Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.

Group Type EXPERIMENTAL

Double-blind Placebo

Intervention Type DRUG

Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)

Open-label Adalimumab

Intervention Type BIOLOGICAL

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study

DB Adalimumab/RE OL Adalimumab

Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.

Group Type EXPERIMENTAL

Double-blind adalimumab

Intervention Type BIOLOGICAL

Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)

Open-label Adalimumab

Intervention Type BIOLOGICAL

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study

Open-labelAdalimumabRescue

Intervention Type BIOLOGICAL

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26

DB Placebo/RE OL Adalimumab

Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.

Group Type EXPERIMENTAL

Double-blind Placebo

Intervention Type DRUG

Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)

Open-label Adalimumab

Intervention Type BIOLOGICAL

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study

Open-labelAdalimumabRescue

Intervention Type BIOLOGICAL

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26

Interventions

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Double-blind adalimumab

Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)

Intervention Type BIOLOGICAL

Double-blind Placebo

Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)

Intervention Type DRUG

Open-label Adalimumab

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study

Intervention Type BIOLOGICAL

Open-labelAdalimumabRescue

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26

Intervention Type BIOLOGICAL

Other Intervention Names

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ABT-D2E7, adalimumab, Humira Placebo ABT-D2E7 adalimumab Humira ABT-D2E7 adalimumab Humira

Eligibility Criteria

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Inclusion Criteria

* Rheumatoid arthritis based on the American College of Rheumatology criteria
* Methotrexate or leflunomide naïve
* Disease duration less than or equal to 2 years from diagnosis

Exclusion Criteria

* History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
* Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus
* Joint surgery involving joints to be assessed within 8 weeks prior to Screening
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hiroshi Ukai, BS

Role: STUDY_DIRECTOR

Abbott Japan Co.,Ltd

Locations

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Site Reference ID/Investigator# 46861

Anjo, , Japan

Site Status

Site Reference ID/Investigator# 46919

Aomori, , Japan

Site Status

Site Reference ID/Investigator# 46805

Chiba, , Japan

Site Status

Site Reference ID/Investigator# 46806

Chiba, , Japan

Site Status

Site Reference ID/Investigator# 46880

Chiba, , Japan

Site Status

Site Reference ID/Investigator# 46881

Chiba, , Japan

Site Status

Site Reference ID/Investigator# 46890

Fuchū, , Japan

Site Status

Site Reference ID/Investigator# 46902

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 46903

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 46904

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 46856

Gifu, , Japan

Site Status

Site Reference ID/Investigator# 46944

Gunma, , Japan

Site Status

Site Reference ID/Investigator# 46893

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 46894

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 12161

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 46916

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 46918

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 46865

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 46871

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 46801

Ibaraki, , Japan

Site Status

Site Reference ID/Investigator# 46925

Ibaraki, , Japan

Site Status

Site Reference ID/Investigator# 46873

Kagoshima, , Japan

Site Status

Site Reference ID/Investigator# 46874

Kagoshima, , Japan

Site Status

Site Reference ID/Investigator# 46845

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 46899

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 46901

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 46851

Kanazawa, , Japan

Site Status

Site Reference ID/Investigator# 46852

Kanazawa, , Japan

Site Status

Site Reference ID/Investigator# 46802

Kawagoe, , Japan

Site Status

Site Reference ID/Investigator# 46900

Kawasaki, , Japan

Site Status

Site Reference ID/Investigator# 46875

Kirishima, , Japan

Site Status

Site Reference ID/Investigator# 46870

Kitakyushu, , Japan

Site Status

Site Reference ID/Investigator# 46872

Kumamoto, , Japan

Site Status

Site Reference ID/Investigator# 46912

Kumamoto, , Japan

Site Status

Site Reference ID/Investigator# 46864

Kyoto, , Japan

Site Status

Site Reference ID/Investigator# 46943

Maebashi, , Japan

Site Status

Site Reference ID/Investigator# 46898

Matsuyama, , Japan

Site Status

Site Reference ID/Investigator# 46915

Miyazaki, , Japan

Site Status

Site Reference ID/Investigator# 46853

Nagano, , Japan

Site Status

Site Reference ID/Investigator# 46855

Nagano, , Japan

Site Status

Site Reference ID/Investigator# 46909

Nagasaki, , Japan

Site Status

Site Reference ID/Investigator# 46910

Nagasaki, , Japan

Site Status

Site Reference ID/Investigator# 46911

Nagasaki, , Japan

Site Status

Site Reference ID/Investigator# 46858

Nagoya, , Japan

Site Status

Site Reference ID/Investigator# 46860

Nagoya, , Japan

Site Status

Site Reference ID/Investigator# 46877

Nara, , Japan

Site Status

Site Reference ID/Investigator# 46885

Nara, , Japan

Site Status

Site Reference ID/Investigator# 46848

Niigata, , Japan

Site Status

Site Reference ID/Investigator# 46906

Niigata, , Japan

Site Status

Site Reference ID/Investigator# 46800

Numakunai, , Japan

Site Status

Site Reference ID/Investigator# 46869

Okayama, , Japan

Site Status

Site Reference ID/Investigator# 46886

Okayama, , Japan

Site Status

Site Reference ID/Investigator# 46887

Okayama, , Japan

Site Status

Site Reference ID/Investigator# 46892

Okayama, , Japan

Site Status

Site Reference ID/Investigator# 46876

Okinawa, , Japan

Site Status

Site Reference ID/Investigator# 46946

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 46947

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 46914

Ōita, , Japan

Site Status

Site Reference ID/Investigator# 46842

Rifu, , Japan

Site Status

Site Reference ID/Investigator# 46846

Sagamihara, , Japan

Site Status

Site Reference ID/Investigator# 46803

Saitama, , Japan

Site Status

Site Reference ID/Investigator# 46804

Saitama, , Japan

Site Status

Site Reference ID/Investigator# 46878

Saitama, , Japan

Site Status

Site Reference ID/Investigator# 46879

Saitama, , Japan

Site Status

Site Reference ID/Investigator# 46917

Sapporo, , Japan

Site Status

Site Reference ID/Investigator# 46942

Shimotsuke, , Japan

Site Status

Site Reference ID/Investigator# 46854

Shizuoka, , Japan

Site Status

Site Reference ID/Investigator# 46857

Shizuoka, , Japan

Site Status

Site Reference ID/Investigator# 46859

Shizuoka, , Japan

Site Status

Site Reference ID/Investigator# 46895

Takamatsu, , Japan

Site Status

Site Reference ID/Investigator# 46843

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 46844

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 46850

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 46882

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 46883

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 46884

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 46888

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 46889

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 46891

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 46896

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 46849

Toyama, , Japan

Site Status

Site Reference ID/Investigator# 46907

Toyama, , Japan

Site Status

Site Reference ID/Investigator# 46862

Toyoake, , Japan

Site Status

Site Reference ID/Investigator# 46866

Toyohashi, , Japan

Site Status

Site Reference ID/Investigator# 46863

Tsu, , Japan

Site Status

Site Reference ID/Investigator# 46926

Tsukuba, , Japan

Site Status

Site Reference ID/Investigator# 46897

Yokohama, , Japan

Site Status

Site Reference ID/Investigator# 46905

Yokohama, , Japan

Site Status

Countries

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Japan

References

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Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

Reference Type DERIVED
PMID: 27338778 (View on PubMed)

Yamanaka H, Ishiguro N, Takeuchi T, Miyasaka N, Mukai M, Matsubara T, Uchida S, Akama H, Kupper H, Arora V, Tanaka Y. Recovery of clinical but not radiographic outcomes by the delayed addition of adalimumab to methotrexate-treated Japanese patients with early rheumatoid arthritis: 52-week results of the HOPEFUL-1 trial. Rheumatology (Oxford). 2014 May;53(5):904-13. doi: 10.1093/rheumatology/ket465. Epub 2014 Jan 17.

Reference Type DERIVED
PMID: 24441150 (View on PubMed)

Other Identifiers

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M06-859

Identifier Type: -

Identifier Source: org_study_id