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Completed

NCT Number: NCT00650156

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 7181

Shanghai, 200001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adalimumab

Biological

40 mg single sc dose

Other names: ABT-D2E7, Humira

Primary outcomes

  1. 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

Secondary outcomes

  1. Adverse event profile

    Time frame: follow up to day 70 after dose

  2. VAS assessments

    Time frame: Days 1, 15 and 29

  3. Swollen and Tender Joint counts

    Time frame: Days 1, 15 and 29

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
First posted
Apr 1, 2008
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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