A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy

AbbVie

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: ABT-494; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01960855

M13-550

2013-002358-57 (EudraCT Number)

Details and patient eligibility

About

The primary objective is to compare the safety and efficacy of multiple doses of ABT-494 versus placebo in moderately to severely active RA subjects on stable background MTX therapy with inadequate response or intolerance to anti-TNF biologic therapy.

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with rheumatoid arthritis (RA) based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months.
• Subjects must have been receiving oral or parenteral methotrexate (MTX) therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should continue with their stable doses of MTX and folic acid throughout the study
• Subjects have been treated with 1 or more anti-tumor necrosis factor (TNF) biologics (no maximum cap) for ≥ 3 months but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity. In addition, subjects with prior exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab, anakinra, or tocilizumab) are allowed.
• Have active RA as defined by the following minimum disease activity criteria: ≥ 6 swollen joints (based on 66 joint counts) at Screening and Baseline, ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline, high sensitivity C reactive protein (hs-CRP) > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) antibody.

Exclusion criteria

• Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib, baricitinib)
• Pregnant or breastfeeding female
• Ongoing or active infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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276 participants in 5 patient groups, including a placebo group

Placebo BID

Placebo Comparator group

Description:

Placebo twice daily (BID) for 12 weeks.

Treatment:

Drug: Placebo

ABT-494 3 mg BID

Experimental group

Description:

ABT-494 3 mg twice daily (BID) for 12 weeks.

Treatment:

Drug: ABT-494

ABT-494 6 mg BID

Experimental group

Description:

ABT-494 6 mg twice daily (BID) for 12 weeks.

Treatment:

Drug: ABT-494

ABT-494 12 mg BID

Experimental group

Description:

ABT-494 12 mg twice daily (BID) for 12 weeks.

Treatment:

Drug: ABT-494

ABT-494 18 mg BID

Experimental group

Description:

ABT-494 18 mg twice daily (BID) for 12 weeks.

Treatment:

Drug: ABT-494