Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)

Conditions

• Early Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• adalimumab — BIOLOGICAL
  Pre-filled syringe every other week
• methotrexate — DRUG
  weekly oral capsule dosing

Study Details

The purpose of this study is to determine the effects of different doses of methotrexate (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).

Key Dates

Start date

Oct 31, 2010

Status verified

Sep 2013

Primary completion

Sep 30, 2012

Completion

Sep 30, 2012

Study Design

Enrollment

395 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: ADA + 2.5 mg MTX
  2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
• Active Comparator: ADA + 5 mg MTX
  5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
• Active Comparator: ADA + 10 mg MTX
  10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
• Active Comparator: ADA + 20 mg MTX
  MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks

Primary Outcome Measure

Percentage of Participants With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) Low Disease Activity at Week 26 [ Time Frame: Week 26 ]

Locations (30)

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