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Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

NCT ID: NCT00647920

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Brief Summary

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A Randomized, Double-Blind, Placebo-Controlled, Study of the Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated with Methotrexate

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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40 mg

Group Type EXPERIMENTAL

adalimumab

Intervention Type BIOLOGICAL

40 mg adalimumab sc, every other week

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

placebo sc, every other week

Interventions

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adalimumab

40 mg adalimumab sc, every other week

Intervention Type BIOLOGICAL

placebo

placebo sc, every other week

Intervention Type BIOLOGICAL

Other Intervention Names

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ABT-D2E7 Humira

Eligibility Criteria

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Inclusion Criteria

* Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits 6 swollen joints and 9 tender joints.

Exclusion Criteria

* A history of, or current, acute inflammatory joint disease of different origin than RA (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritide with onset prior to age 16 years).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Locations

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Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 27338778 (View on PubMed)

Other Identifiers

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M02-573

Identifier Type: -

Identifier Source: org_study_id