NCT00234845

Brief Summary

The purpose of the study is to evaluate the effectiveness of adalimumab in combination with methotrexate compared to methotrexate alone on work disability in subjects with early rheumatoid arthritis

Trial Health

80
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P25-P50 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

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, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
Last Updated

August 29, 2007

Status Verified

August 1, 2007

First QC Date

September 13, 2005

Last Update Submit

August 28, 2007

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Job loss measurement

Secondary Outcomes (4)

  • Job productivity measurements

  • Patient reported outcomes

  • DAS28

  • Safety parameters

Interventions

adalimumabDRUG
methotrexateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
  • Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria
  • Subject must be in paid employment
  • Subject has self-reported work impairment since onset of symptoms

You may not qualify if:

  • A subject has chronic arthritis diagnosed before age 16 years.
  • Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs
  • Subject has preceding treatment with any biological TNF antagonist
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Global Medical Information - Abbott

Abbott Park, Illinois, 60064, United States

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

AdalimumabMethotrexate

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 GlobulinsGlobulinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Beverly Paperiello

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 10, 2005

Study Start

March 1, 2003

Last Updated

August 29, 2007

Record last verified: 2007-08

Locations

US(1)