NCT00647491

Brief Summary

The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
Last Updated

March 31, 2008

Status Verified

March 1, 2008

Enrollment Period

1.3 years

First QC Date

March 27, 2008

Last Update Submit

March 27, 2008

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • ACR20

    Week 24

Secondary Outcomes (3)

  • ACR20

    Week12

  • ACR50

    Weeks 12 and 24

  • ACR70

    Weeks 12 and 24

Study Arms (4)

20 mg

EXPERIMENTAL

20 mg adalimumab eow

Biological: adalimumab

40 mg

EXPERIMENTAL

40 mg adalimumab eow

Biological: adalimumab

80 mg

EXPERIMENTAL

80 mg adalimumab eow

Biological: adalimumab

Placebo

PLACEBO COMPARATOR

Placebo eow

Biological: placebo

Interventions

adalimumabBIOLOGICAL

20 mg sc eow

Also known as: ABT-D2E7, Humira
20 mg
placeboBIOLOGICAL

placebo sc eow

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits \>10 swollen joints, \>12 tender joints.
  • Subjects must have failed prior treatment with one or more DMARDs.
  • A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration.
  • Body weight less than or equal to 100 kg

You may not qualify if:

  • A history of, or current, acute inflammatory joint disease of different origin from RA.
  • Prior treatment with any TNF antagonist, including adalimumab.
  • Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics.
  • Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Ehime, Japan

Location

Unknown Facility

Fukui, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Gunma, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Hyōgo, Japan

Location

Unknown Facility

Ibaraki, Japan

Location

Unknown Facility

Ishikawa, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Kanagawa, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Miyagi, Japan

Location

Unknown Facility

Nagano, Japan

Location

Unknown Facility

Nagasaki, Japan

Location

Unknown Facility

Niigata, Japan

Location

Unknown Facility

Okayama, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Saitama, Japan

Location

Unknown Facility

Shizuoka, Japan

Location

Unknown Facility

Tochigi, Japan

Location

Unknown Facility

Tokushima, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Toyama, Japan

Location

Related Publications (1)

  • 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.

    PMID: 27338778DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Shigeki Hashimoto, Ph.D.

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2008

First Posted

March 31, 2008

Study Start

February 1, 2004

Primary Completion

June 1, 2005

Study Completion

August 1, 2005

Last Updated

March 31, 2008

Record last verified: 2008-03

Locations

JP(25)