CompletedNCT00650156Updated Nov 20, 2017

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

A Phase 1 interventional study of adalimumab and adalimumab in Rheumatoid Arthritis, sponsored by AbbVie. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-20.

Sponsored by AbbVie · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Rheumatoid Arthritis

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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 24 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

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Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

Experimental
40 mg adalimumab
Biological: adalimumab
Experimental
80 mg Adalimumab
Biological: adalimumab

Interventions

Biologicaladalimumab
40 mg single sc dose
Also known as: ABT-D2E7, Humira
Biologicaladalimumab
80 mg single sc dose
Also known as: ABT-D2E7, Humira

What researchers measure

Primary outcomes

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

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

Study locations

1 site

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

References and documents

Publications

Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23. PubMed 27338778 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00650156
Lead sponsor: AbbVie
First posted: Apr 1, 2008
Start date: Jun 2007
Primary completion: Oct 2007
Last update: Nov 20, 2017

Study contacts

Laura Redden, MD

study director · Abbott

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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