Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate

Sponsor
Takeda
Study ID
NCT02393378
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Namilumab — DRUG
    Namilumab injection
  • Adalimumab — DRUG
    Adalimumab SC injection
  • Methotrexate — DRUG
    Methotrexate tablet
  • Folic Acid — DRUG
    Folic Acid Tablet

Study Details

The purpose of this study is to evaluate the efficacy and safety of namilumab in combination with existing methotrexate (MTX) therapy over 24 weeks in participants with moderate to severe early rheumatoid arthritis (RA), diagnosed within 6 months and inadequately controlled by MTX alone.

Key Dates

Start date
Apr 8, 2015
Status verified
Aug 2018
Primary completion
Jun 27, 2016
Completion
Nov 16, 2016

Study Design

Enrollment
7 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab 40 mg
    Adalimumab 40 mg, subcutaneous (SC) injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22 as an add-on to weekly existing stable MTX and folic acid as per prescribed medication.
  • Active Comparator: Namilumab 150 mg
    Namilumab 150\*2 mg, SC injection at Week 0 followed by 150 mg, SC injections at Weeks 2, 6, 10, 14, 18, and 22 as an add-on to weekly existing stable MTX and folic acid as per prescribed medication.

Primary Outcome Measure

Change From Baseline in Synovitis, Erosion and Bone Marrow Edema (Osteitis) Score at Week 24 [ Time Frame: Baseline and Week 24 ]

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