DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Double-blind adalimumab (Biological); Double-blind Placebo (Drug); Open-label Adalimumab (Biological); Open-labelAdalimumabRescue (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Hiroshi Ukai, BS, Study Director, Affiliation: Abbott Japan Co.,Ltd

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.

Clinical Details

Official title: A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Modified Total Sharp X-Ray Score at Week 26

Secondary outcome:

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

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

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

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

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

Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26

Change From Baseline in Modified Total Sharp X-Ray Score at Week 52

Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)

Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)

Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)

Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52

Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52

Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52

Detailed description: 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.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Site Reference ID/Investigator# 46861, Anjo, Japan

Site Reference ID/Investigator# 46919, Aomori, Japan

Site Reference ID/Investigator# 46805, Chiba, Japan

Site Reference ID/Investigator# 46806, Chiba, Japan

Site Reference ID/Investigator# 46880, Chiba, Japan

Site Reference ID/Investigator# 46881, Chiba, Japan

Site Reference ID/Investigator# 46890, Fuchu, Japan

Site Reference ID/Investigator# 46902, Fukuoka, Japan

Site Reference ID/Investigator# 46903, Fukuoka, Japan

Site Reference ID/Investigator# 46904, Fukuoka, Japan

Site Reference ID/Investigator# 46856, Gifu, Japan

Site Reference ID/Investigator# 46944, Gunma, Japan

Site Reference ID/Investigator# 46893, Hiroshima, Japan

Site Reference ID/Investigator# 46894, Hiroshima, Japan

Site Reference ID/Investigator# 12161, Hokkaido, Japan

Site Reference ID/Investigator# 46916, Hokkaido, Japan

Site Reference ID/Investigator# 46918, Hokkaido, Japan

Site Reference ID/Investigator# 46865, Hyogo, Japan

Site Reference ID/Investigator# 46871, Hyogo, Japan

Site Reference ID/Investigator# 46801, Ibaraki, Japan

Site Reference ID/Investigator# 46925, Ibaraki, Japan

Site Reference ID/Investigator# 46800, Iwate, Japan

Site Reference ID/Investigator# 46873, Kagoshima, Japan

Site Reference ID/Investigator# 46874, Kagoshima, Japan

Site Reference ID/Investigator# 46845, Kanagawa, Japan

Site Reference ID/Investigator# 46899, Kanagawa, Japan

Site Reference ID/Investigator# 46901, Kanagawa, Japan

Site Reference ID/Investigator# 46851, Kanazawa, Japan

Site Reference ID/Investigator# 46852, Kanazawa, Japan

Site Reference ID/Investigator# 46802, Kawagoe, Japan

Site Reference ID/Investigator# 46900, Kawasaki, Japan

Site Reference ID/Investigator# 46875, Kirishima, Japan

Site Reference ID/Investigator# 46870, Kitakyushu, Japan

Site Reference ID/Investigator# 46872, Kumamoto, Japan

Site Reference ID/Investigator# 46912, Kumamoto, Japan

Site Reference ID/Investigator# 46864, Kyoto, Japan

Site Reference ID/Investigator# 46943, Maebashi, Japan

Site Reference ID/Investigator# 46898, Matsuyama, Japan

Site Reference ID/Investigator# 46915, Miyazaki, Japan

Site Reference ID/Investigator# 46853, Nagano, Japan

Site Reference ID/Investigator# 46855, Nagano, Japan

Site Reference ID/Investigator# 46909, Nagasaki, Japan

Site Reference ID/Investigator# 46910, Nagasaki, Japan

Site Reference ID/Investigator# 46911, Nagasaki, Japan

Site Reference ID/Investigator# 46858, Nagoya, Japan

Site Reference ID/Investigator# 46860, Nagoya, Japan

Site Reference ID/Investigator# 46877, Nara, Japan

Site Reference ID/Investigator# 46885, Nara, Japan

Site Reference ID/Investigator# 46848, Niigata, Japan

Site Reference ID/Investigator# 46906, Niigata, Japan

Site Reference ID/Investigator# 46914, Oita, Japan

Site Reference ID/Investigator# 46869, Okayama, Japan

Site Reference ID/Investigator# 46886, Okayama, Japan

Site Reference ID/Investigator# 46887, Okayama, Japan

Site Reference ID/Investigator# 46892, Okayama, Japan

Site Reference ID/Investigator# 46876, Okinawa, Japan

Site Reference ID/Investigator# 46946, Osaka, Japan

Site Reference ID/Investigator# 46947, Osaka, Japan

Site Reference ID/Investigator# 46842, Rifu, Japan

Site Reference ID/Investigator# 46846, Sagamihara, Japan

Site Reference ID/Investigator# 46803, Saitama, Japan

Site Reference ID/Investigator# 46804, Saitama, Japan

Site Reference ID/Investigator# 46878, Saitama, Japan

Site Reference ID/Investigator# 46879, Saitama, Japan

Site Reference ID/Investigator# 46917, Sapporo, Japan

Site Reference ID/Investigator# 46942, Shimotsuke, Japan

Site Reference ID/Investigator# 46854, Shizuoka, Japan

Site Reference ID/Investigator# 46857, Shizuoka, Japan

Site Reference ID/Investigator# 46859, Shizuoka, Japan

Site Reference ID/Investigator# 46895, Takamatsu, Japan

Site Reference ID/Investigator# 46843, Tokyo, Japan

Site Reference ID/Investigator# 46844, Tokyo, Japan

Site Reference ID/Investigator# 46850, Tokyo, Japan

Site Reference ID/Investigator# 46882, Tokyo, Japan

Site Reference ID/Investigator# 46883, Tokyo, Japan

Site Reference ID/Investigator# 46884, Tokyo, Japan

Site Reference ID/Investigator# 46888, Tokyo, Japan

Site Reference ID/Investigator# 46889, Tokyo, Japan

Site Reference ID/Investigator# 46891, Tokyo, Japan

Site Reference ID/Investigator# 46896, Tokyo, Japan

Site Reference ID/Investigator# 46849, Toyama, Japan

Site Reference ID/Investigator# 46907, Toyama, Japan

Site Reference ID/Investigator# 46862, Toyoake, Japan

Site Reference ID/Investigator# 46866, Toyohashi, Japan

Site Reference ID/Investigator# 46926, Tsukuba, Japan

Site Reference ID/Investigator# 46863, Tsu, Japan

Site Reference ID/Investigator# 46897, Yokohama, Japan

Site Reference ID/Investigator# 46905, Yokohama, Japan

Additional Information

Starting date: March 2009
Last updated: August 1, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017