A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

NCT00870467 | Completed Phase 3 Results

• 1 other identifier: M06-859
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 88

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Modified Total Sharp X-Ray Score at Week 26

  Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 \[no damage\] to 5 \[complete collapse or total destruction of joint\]) and for joint space narrowing (0 \[no damage\] to 4 \[complete luxation of joint\]). Scores were added, giving 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.

  Baseline, Week 26

Secondary Outcomes (13)

• Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)

  Week 26

• Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)

  Week 26

• Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)

  Week 26

• Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26

  Baseline, Week 26

• Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26

  Week 26

Study Arms (6)

DB Placebo

PLACEBO COMPARATOR

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.

Drug: Double-blind Placebo

DB adalimumab

EXPERIMENTAL

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.

Biological: Double-blind adalimumab

DB Adalimumab/OL Adalimumab

EXPERIMENTAL

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.

Biological: Double-blind adalimumab; Biological: Open-label Adalimumab

DB Placebo/OL Adalimumab

EXPERIMENTAL

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.

Drug: Double-blind Placebo; Biological: Open-label Adalimumab

DB Adalimumab/RE OL Adalimumab

EXPERIMENTAL

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.

Biological: Double-blind adalimumab; Biological: Open-label Adalimumab; Biological: Open-labelAdalimumabRescue

DB Placebo/RE OL Adalimumab

EXPERIMENTAL

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.

Drug: Double-blind Placebo; Biological: Open-label Adalimumab; Biological: Open-labelAdalimumabRescue

Interventions

Double-blind adalimumab BIOLOGICAL

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

Also known as: ABT-D2E7, adalimumab, Humira

DB Adalimumab/OL Adalimumab; DB Adalimumab/RE OL Adalimumab; DB adalimumab

Double-blind Placebo DRUG

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

Also known as: Placebo

DB Placebo; DB Placebo/OL Adalimumab; DB Placebo/RE OL Adalimumab

Open-label Adalimumab BIOLOGICAL

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

Also known as: ABT-D2E7, adalimumab, Humira

DB Adalimumab/OL Adalimumab; DB Adalimumab/RE OL Adalimumab; DB Placebo/OL Adalimumab; DB Placebo/RE OL Adalimumab

Open-labelAdalimumabRescue 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

Also known as: ABT-D2E7, adalimumab, Humira

DB Adalimumab/RE OL Adalimumab; DB Placebo/RE OL Adalimumab

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead
• Eisai Co., Ltd.: collaborator

Study Sites (88)

Site Reference ID/Investigator# 46861

Anjo, Japan

Location

Site Reference ID/Investigator# 46919

Aomori, Japan

Location

Site Reference ID/Investigator# 46805

Chiba, Japan

Location

Site Reference ID/Investigator# 46806

Chiba, Japan

Location

Site Reference ID/Investigator# 46880

Chiba, Japan

Location

Site Reference ID/Investigator# 46881

Chiba, Japan

Location

Site Reference ID/Investigator# 46890

Fuchū, Japan

Location

Site Reference ID/Investigator# 46902

Fukuoka, Japan

Location

Site Reference ID/Investigator# 46903

Fukuoka, Japan

Location

Site Reference ID/Investigator# 46904

Fukuoka, Japan

Location

Site Reference ID/Investigator# 46856

Gifu, Japan

Location

Site Reference ID/Investigator# 46944

Gunma, Japan

Location

Site Reference ID/Investigator# 46893

Hiroshima, Japan

Location

Site Reference ID/Investigator# 46894

Hiroshima, Japan

Location

Site Reference ID/Investigator# 12161

Hokkaido, Japan

Location

Site Reference ID/Investigator# 46916

Hokkaido, Japan

Location

Site Reference ID/Investigator# 46918

Hokkaido, Japan

Location

Site Reference ID/Investigator# 46865

Hyōgo, Japan

Location

Site Reference ID/Investigator# 46871

Hyōgo, Japan

Location

Site Reference ID/Investigator# 46801

Ibaraki, Japan

Location

Site Reference ID/Investigator# 46925

Ibaraki, Japan

Location

Site Reference ID/Investigator# 46873

Kagoshima, Japan

Location

Site Reference ID/Investigator# 46874

Kagoshima, Japan

Location

Site Reference ID/Investigator# 46845

Kanagawa, Japan

Location

Site Reference ID/Investigator# 46899

Kanagawa, Japan

Location

Site Reference ID/Investigator# 46901

Kanagawa, Japan

Location

Site Reference ID/Investigator# 46851

Kanazawa, Japan

Location

Site Reference ID/Investigator# 46852

Kanazawa, Japan

Location

Site Reference ID/Investigator# 46802

Kawagoe, Japan

Location

Site Reference ID/Investigator# 46900

Kawasaki, Japan

Location

Site Reference ID/Investigator# 46875

Kirishima, Japan

Location

Site Reference ID/Investigator# 46870

Kitakyushu, Japan

Location

Site Reference ID/Investigator# 46872

Kumamoto, Japan

Location

Site Reference ID/Investigator# 46912

Kumamoto, Japan

Location

Site Reference ID/Investigator# 46864

Kyoto, Japan

Location

Site Reference ID/Investigator# 46943

Maebashi, Japan

Location

Site Reference ID/Investigator# 46898

Matsuyama, Japan

Location

Site Reference ID/Investigator# 46915

Miyazaki, Japan

Location

Site Reference ID/Investigator# 46853

Nagano, Japan

Location

Site Reference ID/Investigator# 46855

Nagano, Japan

Location

Site Reference ID/Investigator# 46909

Nagasaki, Japan

Location

Site Reference ID/Investigator# 46910

Nagasaki, Japan

Location

Site Reference ID/Investigator# 46911

Nagasaki, Japan

Location

Site Reference ID/Investigator# 46858

Nagoya, Japan

Location

Site Reference ID/Investigator# 46860

Nagoya, Japan

Location

Site Reference ID/Investigator# 46877

Nara, Japan

Location

Site Reference ID/Investigator# 46885

Nara, Japan

Location

Site Reference ID/Investigator# 46848

Niigata, Japan

Location

Site Reference ID/Investigator# 46906

Niigata, Japan

Location

Site Reference ID/Investigator# 46800

Numakunai, Japan

Location

Site Reference ID/Investigator# 46869

Okayama, Japan

Location

Site Reference ID/Investigator# 46886

Okayama, Japan

Location

Site Reference ID/Investigator# 46887

Okayama, Japan

Location

Site Reference ID/Investigator# 46892

Okayama, Japan

Location

Site Reference ID/Investigator# 46876

Okinawa, Japan

Location

Site Reference ID/Investigator# 46946

Osaka, Japan

Location

Site Reference ID/Investigator# 46947

Osaka, Japan

Location

Site Reference ID/Investigator# 46914

Ōita, Japan

Location

Site Reference ID/Investigator# 46842

Rifu, Japan

Location

Site Reference ID/Investigator# 46846

Sagamihara, Japan

Location

Site Reference ID/Investigator# 46803

Saitama, Japan

Location

Site Reference ID/Investigator# 46804

Saitama, Japan

Location

Site Reference ID/Investigator# 46878

Saitama, Japan

Location

Site Reference ID/Investigator# 46879

Saitama, Japan

Location

Site Reference ID/Investigator# 46917

Sapporo, Japan

Location

Site Reference ID/Investigator# 46942

Shimotsuke, Japan

Location

Site Reference ID/Investigator# 46854

Shizuoka, Japan

Location

Site Reference ID/Investigator# 46857

Shizuoka, Japan

Location

Site Reference ID/Investigator# 46859

Shizuoka, Japan

Location

Site Reference ID/Investigator# 46895

Takamatsu, Japan

Location

Site Reference ID/Investigator# 46843

Tokyo, Japan

Location

Site Reference ID/Investigator# 46844

Tokyo, Japan

Location

Site Reference ID/Investigator# 46850

Tokyo, Japan

Location

Site Reference ID/Investigator# 46882

Tokyo, Japan

Location

Site Reference ID/Investigator# 46883

Tokyo, Japan

Location

Site Reference ID/Investigator# 46884

Tokyo, Japan

Location

Site Reference ID/Investigator# 46888

Tokyo, Japan

Location

Site Reference ID/Investigator# 46889

Tokyo, Japan

Location

Site Reference ID/Investigator# 46891

Tokyo, Japan

Location

Site Reference ID/Investigator# 46896

Tokyo, Japan

Location

Site Reference ID/Investigator# 46849

Toyama, Japan

Location

Site Reference ID/Investigator# 46907

Toyama, Japan

Location

Site Reference ID/Investigator# 46862

Toyoake, Japan

Location

Site Reference ID/Investigator# 46866

Toyohashi, Japan

Location

Site Reference ID/Investigator# 46863

Tsu, Japan

Location

Site Reference ID/Investigator# 46926

Tsukuba, Japan

Location

Site Reference ID/Investigator# 46897

Yokohama, Japan

Location

Site Reference ID/Investigator# 46905

Yokohama, Japan

Location

Related Publications (2)

• 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.

  PMID: 27338778 DERIVED

• 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.

  PMID: 24441150 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Hiroshi Ukai, BS

  Abbott Japan Co.,Ltd

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 7, 2012
• Results First Posted: April 5, 2012

Record last verified: 2012-08

Locations

JP (88)