Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Long-term Continuously Repeated Dose Study of Adalimumab (D2E7) in Patients With Rheumatoid Arthritis

The purpose of the study is to assess the long-term safety, tolerability, and efficacy of repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: adalimumab

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Metropolis
    • Tokyo, Metropolis, Japan
  • Prefecture
    • Fukuoka, Prefecture, Japan
    • Hiroshima, Prefecture, Japan
    • Ibaraki, Prefecture, Japan
    • Nagasaki, Prefecture, Japan
    • Osaka, Prefecture, Japan
    • Saitama, Prefecture, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participation in the prior adalimumab study
• Body weight less than 100 kg.
• Subject's who wished to continue the study drug administration
• Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.

Exclusion Criteria:

• A subject who experienced any of the following during the prior adalimumab sc dosing study:

  • Advanced or poorly controlled diabetes
  • Any poorly controlled medical condition
  • Intra-articular, intramuscular or iv administration of corticosteroids
  • Joint surgery.
• A subject who has been prescribed excluded medications during previous adalimumab study.
• History of clinically significant drug or alcohol abuse, intravenous (iv) drug abuse, active infection with listeria or tuberculosis (TB), lymphoma, leukemia, or any malignancy with the exception of successfully treated non- metastatic basal cell carcinoma of the skin.
• A subject who experienced chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 30 days of entry into study or chronic use of oral antibiotics within 14 days of entry into study.
• Preexisting or recent onset of central nervous system (CNS) demyelinating disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adalimumab 40 mg eow	Biological: adalimumab; 40 mg every other week (eow), subcutaneous (sc); Other Names: ABT-D2E7; Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)	Number of subjects with American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts [TJC or SJC, respectively] and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: [1] physician's global assessment of disease activity [PGA], [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of functional disability via a health assessment questionnaire [HAQ], and [5] C-reactive protein [CRP]) at each visit	Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit	Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in tender joint count (TJC, max = 68), a component of the ACR criteria, by visit	Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit	Mean change from baseline(last assessment in preceding study prior to adalimumab injection) in the SJC (max = 66) component of the ACR criteria	Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit	Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst possible assessment), a component of the ACR criteria, by visit.	Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit	Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit	Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit	Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's assessment of pain (using a visual analog scale from 0 - 100 mm with 100 mm being the worst possible pain), a component of the ACR criteria, by visit	Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit	Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in disability index of the health assessment questionnaire [HAQ; includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so).], a component the of ACR criteria, by visit	Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.	Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in C-reactive protein [CRP; mg/dL], a component of the ACR criteria, by visit.	Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)	Sum of the duration (from start of study to each study visit) when a subject with American College of Rheumatology (ACR) criteria improved by 20% (ACR20) in tender or swollen joint counts [TJC or SJC, respectively] and 20% improvement in 3 of the following 5 criteria: [1] Physician's global assessment (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of functional disability via a health assessment questionnaire [HAQ], and [5] C-reactive protein (CRP)	Every 6 weeks up to Week 24 and every 12 weeks thereafter
Number of Subjects With Morning Stiffness at Each Visit	The number of subjects with morning stiffness (assessed as present or absent) at each visit among those who had morning stiffness at baseline (21).	Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: Eisai Co., Ltd.; Abbott Japan Co.,Ltd
• Investigators: Study Director: Shigeki Hashimoto, Ph.D., Abbott

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: October 7, 2005
• First Submitted That Met QC Criteria: October 11, 2005
• First Posted (Estimate): October 12, 2005

Study Record Updates

• Last Update Posted (Estimate): April 11, 2011
• Last Update Submitted That Met QC Criteria: April 7, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: M02-564