Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Filgotinib — DRUG
  200 mg or 100 mg tablet(s) administered orally once daily
• Placebo to match filgotinib — DRUG
  Tablet(s) administered orally once daily
• Adalimumab — DRUG
  40 mg administered via subcutaneous injection once every two weeks
• Placebo to match adalimumab — DRUG
  Administered via subcutaneous injection once every two weeks
• MTX — DRUG
  Commercially sourced tablet(s) administered orally

Study Details

The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.

Key Dates

Start date

Aug 30, 2016

Status verified

May 2021

Primary completion

Jul 4, 2018

Completion

Jun 20, 2019

Study Design

Enrollment

1,759 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Filgotinib 200 mg
  Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of methotrexate (MTX)
• Experimental: Filgotinib 100 mg
  Filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX
• Active Comparator: Adalimumab
  Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + adalimumab 40 mg in addition to a stable dose of MTX
• Experimental: Placebo to Filgotinib 200 mg
  Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 200 mg to receive filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.
• Experimental: Placebo to Filgotinib 100 mg
  Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 100 mg to receive filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.
• Placebo Comparator: Placebo Never Received Filgotinib
  Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks.

Primary Outcome Measure

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 [ Time Frame: Week 12 ]

Locations (48)

Find similar trials in Huntsville, AL

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