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Adalimumab in Adult 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: adalimumab (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Shigeki Hashimoto, Ph.D., Study Director, Affiliation: Abbott

Summary

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)

Secondary outcome:

Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit

Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit

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 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 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 in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit

Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.

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)

Number of Subjects With Morning Stiffness at Each Visit

Eligibility

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

Criteria:

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.

Locations and Contacts

Tokyo, Metropolis, Japan

Fukuoka, Prefecture, Japan

Hiroshima, Prefecture, Japan

Ibaraki, Prefecture, Japan

Nagasaki, Prefecture, Japan

Osaka, Prefecture, Japan

Saitama, Prefecture, Japan

Additional Information

Starting date: June 2003
Last updated: April 7, 2011

Page last updated: August 23, 2015

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