NCT00603993

Brief Summary

The purpose of this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label study.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

16 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

March 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 4, 2010

Completed
Last Updated

June 21, 2011

Status Verified

June 1, 2011

Enrollment Period

8 months

First QC Date

January 10, 2008

Results QC Date

October 16, 2009

Last Update Submit

June 17, 2011

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)

    Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: \[1\] physician's global assessment of disease activity (PGA), \[2\] subject's assessment of disease activity, \[3\] subject's assessment of pain, \[4\] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and \[5\] C-reactive protein (CRP) at each visit.

    Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)

Secondary Outcomes (9)

  • Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit

    Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)

  • Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit

    Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)

  • Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit

    Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)

  • Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit

    Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)

  • Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit

    Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)

  • +4 more secondary outcomes

Study Arms (1)

Adalimumab

EXPERIMENTAL

Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT 00235872\]) subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan

Biological: Adalimumab

Interventions

AdalimumabBIOLOGICAL

40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection

Also known as: Humira, ABT-D2E7
Adalimumab

Eligibility Criteria

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

You may qualify if:

  • Completed Week 36 of Study M03-651 \[NCT 00235872\]
  • Wish to participate in self-injection study
  • Give written informed consent
  • Comply with protocol requirements

You may not qualify if:

  • Subject develops serious adverse events at time of eligibility confirmation
  • Subject develops severe infections requiring hospitalization or IV injection of antibiotics within 28 days before eligibility confirmation
  • Subject develops infections requiring oral administration of antibiotics within 14 days before eligibility confirmation
  • The investigator considers the subject inappropriate for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Chiba, 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

Kanagawa, Japan

Location

Unknown Facility

Miyagi, Japan

Location

Unknown Facility

Nagano, Japan

Location

Unknown Facility

Okayama, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Saitama, Japan

Location

Unknown Facility

Shizuoka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Toyama, Japan

Location

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

Limitations and Caveats

Due to the small population, statistical tests were not performed.

Results Point of Contact

Title
Global Medical Services
Organization
Abbott
1-800-633-9110

Study Officials

  • Shigeki Hashimoto, PhD

    Abbott Japan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 29, 2008

Study Start

March 1, 2006

Primary Completion

November 1, 2006

Last Updated

June 21, 2011

Results First Posted

February 4, 2010

Record last verified: 2011-06

Locations

JP(16)