Rheumatoid ArthritisPhase 1NCT01741493
A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494
A Phase 1 study testing ABT-494 and Tofacitinib in people with Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott) at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ABT-494 and Tofacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2012to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Site Reference ID/Investigator# 92153
Austin, Texas, 78744
Site Reference ID/Investigator# 95816
Cincinnati, Ohio, 45255
Site Reference ID/Investigator# 95815
Duncansville, Pennsylvania, 16635
Site Reference ID/Investigator# 95817
Miami, Florida, 33136
Site Reference ID/Investigator# 97177
Orem, Utah, 84058
About this study
Official title: A Study in Healthy Adult Volunteers and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Dosing of ABT-494
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.
Read the detailed description
To assess the safety, tolerability and pharmacokinetics of ABT-494 in healthy volunteers and in patients with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ABT-494, Placebo, Tofacitinib
- Keywords
- Rheumatoid Arthritis, Methotrexate, Tolerability, Pharmacokinetics, Safety, Tofacitinib
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-494Drug
Oral administration of ABT-494 capsules
PlaceboDrug
Oral administration of placebo capsules
TofacitinibDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers (ABT-494) | Experimental | Multiple dosing of ABT-494 in healthy volunteers Receives: Drug: ABT-494 |
| Rheumatoid Arthritis Patients | Experimental | Multiple dosing of ABT-494 in patients with rheumatoid arthritis Receives: Drug: ABT-494 |
| No treatment | Placebo comparator | Placebo administration in healthy volunteers and patients with rheumatoid arthritis Receives: Drug: Placebo |
| Healthy Volunteers (tofa) | Other | Multiple dosing of tofacitinib in healthy volunteers Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants with Adverse Events
Measured: From first dose up to 28 days after the last dose of study drug
Vital Signs
Blood pressure, pulse rate and body temperature
Measured: From first dose up to 28 days after the last dose of study drug
Clinical Lab testing
Hematology, Chemistry, and Urinalysis
Measured: From date of first dose up to 28 days after the last dose of study drug
Electrocardiogram (ECG)
ECGs done in triplicate; heart rate, PR interval, QT/QTc interval and QRS duration
Measured: Prior to first dose, during first dose interval, prior to last dose and until 24 hours post last dose
Pharmacokinetics of ABT-494
Cmax, Tmax, AUC, elimination rate constant and half-life
Measured: Prior to first dose up to 72 hours after the last dose of ABT-494
Secondary outcomes (1)
Pharmacokinetics of Methotrexate
Cmax, Tmax, AUC, elimination rate constant and half-life
Measured: Prior to first dose up to 48 hours after the last dose of methotrexate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Jungerwirth, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741493
- Sponsor's protocol ID
- M13-845
- Status last verified
- Jan 2014
- First submitted
- 3 Dec 2012
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mohamed MF, Camp HS, Jiang P, Padley RJ, Asatryan A, Othman AA. Pharmacokinetics, Safety and Tolerability of ABT-494, a Novel Selective JAK 1 Inhibitor, in Healthy Volunteers and Subjects with Rheumatoid Arthritis. Clin Pharmacokinet. 2016 Dec;55(12):1547-1558. doi: 10.1007/s40262-016-0419-y.
PubMed 27272171Klunder B, Mohamed MF, Othman AA. Population Pharmacokinetics of Upadacitinib in Healthy Subjects and Subjects with Rheumatoid Arthritis: Analyses of Phase I and II Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):977-988. doi: 10.1007/s40262-017-0605-6.
PubMed 29076110
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Healthy Adult Volunteers and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Dosing of ABT-494
- ClinicalTrials.gov ID
- NCT01741493
- Acronym / sponsor ID
- M13-845
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Methotrexate, Tolerability, Pharmacokinetics, Safety, Tofacitinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers (ABT-494) | Experimental | Drug: ABT-494Multiple dosing of ABT-494 in healthy volunteers |
| Rheumatoid Arthritis Patients | Experimental | Drug: ABT-494Multiple dosing of ABT-494 in patients with rheumatoid arthritis |
| No treatment | Placebo comparator | Drug: PlaceboPlacebo administration in healthy volunteers and patients with rheumatoid arthritis |
| Healthy Volunteers (tofa) | Other | Drug: TofacitinibMultiple dosing of tofacitinib in healthy volunteers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects 18 to 55 years of age, inclusive.
- Subject is judged to be in good general health.
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-494Oral administration of ABT-494 capsules | Drug | Healthy Volunteers (ABT-494), Rheumatoid Arthritis Patients |
| PlaceboOral administration of placebo capsules | Drug | No treatment |
| TofacitinibOral administration | Drug | Healthy Volunteers (tofa) |
Primary outcome
Number and percentage of participants with Adverse Events
Time frame: From first dose up to 28 days after the last dose of study drug
Vital Signs
Time frame: From first dose up to 28 days after the last dose of study drug
Blood pressure, pulse rate and body temperature
Clinical Lab testing
Time frame: From date of first dose up to 28 days after the last dose of study drug
Hematology, Chemistry, and Urinalysis
Electrocardiogram (ECG)
Time frame: 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
Time frame: Prior to first dose up to 72 hours after the last dose of ABT-494
Cmax, Tmax, AUC, elimination rate constant and half-life
1 secondary outcome
Pharmacokinetics of Methotrexate
Time frame: Prior to first dose up to 48 hours after the last dose of methotrexate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Results publication: PubMed 27272171Mohamed MF, Camp HS, Jiang P, Padley RJ, Asatryan A, Othman AA. Pharmacokinetics, Safety and Tolerability of ABT-494, a Novel Selective JAK 1 Inhibitor, in Healthy Volunteers and Subjects with Rheumatoid Arthritis. Clin Pharmacokinet. 2016 Dec;55(12):1547-1558. doi: 10.1007/s40262-016-0419-y.
- Derived from this study: PubMed 29076110Klunder B, Mohamed MF, Othman AA. Population Pharmacokinetics of Upadacitinib in Healthy Subjects and Subjects with Rheumatoid Arthritis: Analyses of Phase I and II Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):977-988. doi: 10.1007/s40262-017-0605-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Jungerwirth, MD study director
AbbVie
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-494 and Tofacitinib in people with Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of participants with Adverse Events (time frame: From first dose up to 28 days after the last dose of study drug). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01741493, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.