Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Methotrexate, Tolerability, Pharmacokinetics, Safety, Tofacitinib
Brief summary
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.
Detailed description
To assess the safety, tolerability and pharmacokinetics of ABT-494 in healthy volunteers and in patients with rheumatoid arthritis.
Interventions
DRUGTofacitinib
Oral administration
DRUGABT-494
Oral administration of ABT-494 capsules
DRUGPlacebo
Oral administration of placebo capsules
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and percentage of participants with Adverse Events | From first dose up to 28 days after the last dose of study drug | — |
| Vital Signs | From first dose up to 28 days after the last dose of study drug | Blood pressure, pulse rate and body temperature |
| Clinical Lab testing | From date of first dose up to 28 days after the last dose of study drug | Hematology, Chemistry, and Urinalysis |
| Electrocardiogram (ECG) | Prior to first dose, during first dose interval, prior to last dose and until 24 hours post last dose | ECGs done in triplicate; heart rate, PR interval, QT/QTc interval and QRS duration |
| Pharmacokinetics of ABT-494 | Prior to first dose up to 72 hours after the last dose of ABT-494 | Cmax, Tmax, AUC, elimination rate constant and half-life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of Methotrexate | Prior to first dose up to 48 hours after the last dose of methotrexate | Cmax, Tmax, AUC, elimination rate constant and half-life |
Countries
United States
Outcome results
None listed