Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis

November 16, 2017 updated by: AbbVie

A Randomized, Parallel-group, Open-Label, Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis.

Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid Arthritis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200001
        • Site Reference ID/Investigator# 7181

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female ages 18 years and older.
  • Mild RA.
  • Body weight less than 100 kg.

Exclusion Criteria:

  • Wheelchair-bound or bedridden.
  • Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit.
  • Intra-articular, intramuscular or intravenous (IV) administration of corticosteroids within 28 days prior to the Screening visit.
  • Prior treatment with any TNF antagonist, including adalimumab.
  • Positive tuberculin PPD 5.
  • Female subjects who are pregnant or breast-feeding.
  • History of HIV or of being immuno-compromised.
  • History of malignancy.
  • Poorly controlled medical condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 40 mg adalimumab
Biological: adalimumab
40 mg single sc dose
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
80 mg single sc dose
Other Names:
  • ABT-D2E7
  • Humira
EXPERIMENTAL: 80 mg Adalimumab
Biological: adalimumab
40 mg single sc dose
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
80 mg single sc dose
Other Names:
  • ABT-D2E7
  • Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab
Time Frame: Days 1, 2, 4, 6, 8, 11, 15, 22, & 29
Days 1, 2, 4, 6, 8, 11, 15, 22, & 29

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse event profile
Time Frame: follow up to day 70 after dose
follow up to day 70 after dose
VAS assessments
Time Frame: Days 1, 15 and 29
Days 1, 15 and 29
Swollen and Tender Joint counts
Time Frame: Days 1, 15 and 29
Days 1, 15 and 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (ESTIMATE)

April 1, 2008

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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