SELECT- SWITCH
Brief summary
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Interventional study
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Please note, participation in the clinical trial is open to patients with the disease or condition under investigation. |
Age:
18 Years and older.
Inclusion Criteria:
- Diagnosis of Rheumatoid Arthritis (RA) for >= 3 months based on the 2010 American
College of Rheumatology/European Alliance of Associations for Rheumatology
(ACR/EULAR) classification criteria for RA.
- Treated for >= 3 consecutive months prior to screening with 1 tumor necrosis factor
inhibitor (TNFi) (only 1 of originator or biosimilar certolizumab pegol, etanercept,
golimumab or infliximab) for RA, but continue to exhibit active RA, or had to
discontinue due to intolerability or toxicity, irrespective of treatment duration.
Up to 15% of participants who were intolerant to 1 TNFi will be allowed to enroll.
Prior administration of different biosimilar versions for the same originator TNFi
or switching between originator and biosimilar version of the same originator TNFi
are acceptable. Cycling between biosimilars of different originator TNF inhibitors
is not acceptable.
- On oral or parenteral methotrexate (MTX) therapy >= 3 consecutive months and on a
stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant
of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug.
In addition, all participants should take a dietary supplement of folic acid or
folinic acid throughout the study participation.
- For a Chinese, Japanese, Korean, or Taiwanese participant, a stable dose of MTX
>= 7.5 mg/week is acceptable.
- Additional local requirements for MTX may apply.
- Meets both of the following disease activity criteria:
- >= 6 swollen joint (based on 66 joint counts) and >= 6 tender joints (based on
68 joint counts) at screening and baseline;
- High-sensitivity C-reactive protein (hsCRP) >= 3 mg/L (central lab, upper limit
of normal [ULN] 2.87 mg/L) at screening.
Exclusion Criteria:
- History of any arthritis with onset prior to age 17 years or current diagnosis of
inflammatory joint disease other than Rheumatoid Arthritis (RA).
- Prior exposure to any janus kinase (JAK) inhibitor.
- Prior exposure to adalimumab (original or biosimilar) or to any approved or
investigational TNF inhibitor other than infliximab, etanercept, certolizumab pegol
and golimumab.
- Prior exposure to an approved or investigational non-TNFi biologic disease modifying
anti-rheumatic drug (bDMARD) or targeted synthetic disease modifying antirheumatic
drug (tsDMARD).
