Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study

Sponsor
AbbVie
Study ID
NCT02196701
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Administered by subcutaneous injection every other week.
  • Methotrexate — DRUG
    Methotrexate was provided as 2.5 mg tablets for oral administration.

Study Details

The purpose of this study is to determine the safety and efficacy of the use of the combination therapy adalimumab (ADA) every other week (EOW) with methotrexate (MTX) in suboptimal responders to ADA monotherapy.

Key Dates

Start date
Aug 5, 2014
Status verified
Jan 2018
Primary completion
Mar 17, 2017
Completion
Mar 17, 2017

Study Design

Enrollment
46 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab Plus Methotrexate
    Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.

Primary Outcome Measure

Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment [ Time Frame: Week 16 ]

Related Studies