NCT00234936

Brief Summary

The purpose of the study is to evaluate the ability of adalimumab combined with methotrexate to improve the quality of life in patients with active RA.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 rheumatoid-arthritis

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

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
Last Updated

October 3, 2007

Status Verified

October 1, 2007

First QC Date

September 16, 2005

Last Update Submit

October 2, 2007

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisadalimumabquality of life

Outcome Measures

Primary Outcomes (1)

  • QOL

    12 months

Secondary Outcomes (3)

  • Patient reported outcomes

  • Clinical response indicators

  • 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 ACR criteria
  • Subjects with treatment failure criteria to Mtx or Mtx + another DMARD

You may not qualify if:

  • 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
  • Previous treatment with approved biological agents (etanercept, infliximab, anakinra) in the last 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Global Medical Information

    Abbott

    STUDY DIRECTOR

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

September 16, 2005

First Posted

October 10, 2005

Study Start

December 1, 2003

Last Updated

October 3, 2007

Record last verified: 2007-10