A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494

AbbVie

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: ABT-494; Drug: Placebo; Drug: Tofacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01741493

M13-845

Details and patient eligibility

About

This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study in healthy volunteers, multiple dose study in patients with rheumatoid arthritis and multiple dose study in healthy volunteers.

Full description

To assess the safety, tolerability and pharmacokinetics of ABT-494 in healthy volunteers and in patients with rheumatoid arthritis.

Enrollment: 67 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy Volunteers:

• Male and female subjects 18 to 55 years of age, inclusive.
• Subject is judged to be in good general health.

Rheumatoid Arthritis Patients:

• Male and female patients 18 to 75 years of age, inclusive.
• Subject has a diagnosis of rheumatoid arthritis for at least six months.
• Subject has been on methotrexate therapy for at least three months and on a stable dose for at least four weeks.

Exclusion criteria

• History or evidence of active or latent tuberculosis.
• History or significant allergic reaction to any drug.
• Use of known strong CYP3A and CYP2D6 inhibitors and CYP3A inducers within 21 days or within 5 half-lives of the respective medication, whichever is longer.
• Current or expected need for oral intake of at least 10 mg prednisone per day or equivalent corticosteroid therapy.
• History of acute inflammatory joint disease of different origin other than rheumatoid arthritis (rheumatoid arthritis patients).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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67 participants in 4 patient groups, including a placebo group

Healthy Volunteers (ABT-494)

Experimental group

Description:

Multiple dosing of ABT-494 in healthy volunteers

Treatment:

Drug: ABT-494

Rheumatoid Arthritis Patients

Experimental group

Description:

Multiple dosing of ABT-494 in patients with rheumatoid arthritis

Treatment:

Drug: ABT-494

No treatment

Placebo Comparator group

Description:

Placebo administration in healthy volunteers and patients with rheumatoid arthritis

Treatment:

Drug: Placebo

Healthy Volunteers (tofa)

Other group

Description:

Multiple dosing of tofacitinib in healthy volunteers

Treatment:

Drug: Tofacitinib