SELECT-EARLY

A Study to Compare an Active Drug Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

Brief summary

The objectives of Period 1 were the following:

1. To compare the safety and efficacy of an active drug 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in methotrexate-naïve adults with moderately to severely active RA;

2. To compare the efficacy of an active drug 15 mg QD monotherapy and an active drug 30 mg QD monotherapy versus weekly methotrexate monotherapy for prevention of structural progression in methotrexate-naïve adults with moderately to severely active RA.

The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of an active drug 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults with RA who have completed Period 1.

Interventional study

Status:
Active, not recruiting
Conditions:
Rheumatoid Arthritis
Enrollment:
1002 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M13-545
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

- Duration of symptoms consistent with RA for ≥ 6 weeks who also fulfill the 2010
American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
classification criteria for RA.

- Naïve to Methotrexate (MTX) or, if already on MTX, have received no more than 3 weekly
MTX doses with requirement to complete a 4-week MTX washout before the first dose of
study drug.

- Participants with prior exposure to conventional synthetic disease-modifying
anti-rheumatic drugs(csDMARDs) other than MTX may be enrolled if completed the washout
period.

- Participant meets both of the following minimum disease activity criteria:

-≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68
joint counts) at Screening and Baseline Visits.

- high sensitivity C reactive protein (hsCRP) ≥ 5 mg/L (central lab, upper limit of
normal [ULN] 2.87 mg/L at Screening Visit.

- Greater than or equal to 1 bone erosion on x-ray (by local reading) OR in the absence
of documented bone erosion, both positive rheumatoid factor (RF) and positive
anti-cyclic citrullinated peptide (anti CCP) autoantibodies are required at Screening.

- Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral
corticosteroids (equivalent to prednisone ≤ 10 mg/day), or inhaled corticosteroids for
stable medical conditions are allowed but must have been at a stable dose ≥ 1 week
prior to the first dose of study drug.

Exclusion Criteria:

- Intolerant to Methotrexate (MTX).

- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
tofacitinib, baricitinib, and filgotinib).

- Prior exposure to any biologic disease-modifying anti-rheumatic drugs (bDMARDs).

- History of any arthritis with onset prior to age 17 years or current diagnosis,
inflammatory joint disease other than RA (including but not limited to gout, systemic
lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing
spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap
connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia
[currently with active symptoms]. Current diagnosis of secondary Sjogren's Syndrome is
permitted.

- Has been treated with intra-articular, intramuscular, intravenous, trigger point or
tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8
weeks prior to the first dose of study drug.

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