Rheumatoid ArthritisPhase 2NCT01626573
A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis
A Phase 2 study testing Itacitinib in people with Rheumatoid Arthritis, run by Incyte Corporation at 18 sites in 2 countries.
Trial summary
This is a study evaluating a 28-day course followed by a 56-day course of itacitinib in patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy parameters of itacitinib. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Itacitinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Mar 2012to Oct 2013
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with active RA aged 18 to 75 years of age and meet tender and swollen joint assessment expectations defined in the study protocol.
- c-Reactive protein (CRP) or erythrocyte sedimentation rate (ESR) laboratory values meet minimal study protocol expectations.
Who cannot join
- Females who are pregnant or breastfeeding.
- Men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.
- Subjects treated with a biologic agent within 12 weeks prior to first dose of study drug. (12 months in the case of rituximab.)
- Subjects with a history or currently suspected inflammatory disease other than RA.
- Subjects with a history of hematological disorders.
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States17 sites
Study site
Austin, Texas
Study site
Duncansville, Pennsylvania
Study site
Florence, South Carolina
Study site
Katy, Texas
Study site
Lake Mary, Florida
Study site
Lansing, Michigan
Study site
Lexington, Kentucky
Study site
Middleburg Heights, Ohio
Study site
Ocala, Florida
Study site
Palm Desert, California
Study site
Palm Harbor, Florida
Study site
Pasadena, California
Study site
Raleigh, North Carolina
Study site
Spokane, Washington
Study site
Tampa, Florida
Study site
Tavares, Florida
Study site
Worcester, Massachusetts
About this study
Official title: A Double- Blind, Placebo Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis
This is a study evaluating a 28-day course followed by a 56-day course of itacitinib in patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy parameters of itacitinib.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Itacitinib, Itacitinib Placebo
- Keywords
- Rheumatoid Arthritis, RA, Active
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItacitinibDrug
Also called INCB039110
Itacitinib PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Itacitinib 400 mg twice a day | Experimental | Itacitinib 400 mg twice a day Receives: Drug: Itacitinib |
| Itacitinib 400 mg placebo twice a day | Placebo comparator | Itacitinib 400 mg placebo twice a day Receives: Drug: Itacitinib Placebo |
| Itacitinib 100 mg twice a day | Experimental | This dose group will be studied twice during the study. Receives: Drug: Itacitinib |
| Itacitinib 100 mg placebo twice a day | Placebo comparator | This dose group will be studied twice during the study. Receives: Drug: Itacitinib Placebo |
| Itacitinib 100mg once a day | Experimental | Itacitinib 100mg once a day Receives: Drug: Itacitinib |
| Itacitinib 100 mg placebo once a day | Placebo comparator | Itacitinib 100 mg placebo once a day Receives: Drug: Itacitinib Placebo |
| Itacitinib 200 mg twice a day | Experimental | Itacitinib 200 mg twice a day Receives: Drug: Itacitinib |
| Itacitinib 200 mg placebo twice a day | Placebo comparator | Itacitinib 200 mg placebo twice a day Receives: Drug: Itacitinib Placebo |
| Itacitinib 300 mg once a day | Experimental | Itacitinib 300 mg once a day Receives: Drug: Itacitinib |
| Itacitinib 300 mg placebo once a day | Placebo comparator | Itacitinib 300 mg placebo once a day Receives: Drug: Itacitinib Placebo |
| Itacitinib 600 mg once a day | Experimental | Itacitinib 600 mg once a day Receives: Drug: Itacitinib |
| Itacitinib 600 mg placebo once a day | Placebo comparator | Itacitinib 600 mg placebo once a day Receives: Drug: Itacitinib Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of itacitinib as assessed by the changes in frequency and severity of adverse events, ECGs, vital signs, physical examinations, and clinical laboratory evaluations.
Measured: Approximately four months.
Preliminary efficacy as assessed by the percentage of patients achieving ACR20 improvement from baseline on the day 28 and day 84 visits.
Measured: Approximately 84 days.
Secondary outcomes (1)
Preliminary Pharmacokinetic (PK) collections.
Plasma concentrations of itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).
Measured: Following 15 days of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victor Sandor, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626573
- Sponsor's protocol ID
- 39110-201
- Status last verified
- Mar 2019
- First submitted
- 3 May 2012
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double- Blind, Placebo Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01626573
- Acronym / sponsor ID
- 39110-201
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, RA, Active
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Jun 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 study evaluating a 28-day course followed by a 56-day course of itacitinib in patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy parameters of itacitinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Itacitinib 400 mg twice a day | Experimental | Drug: ItacitinibItacitinib 400 mg twice a day |
| Itacitinib 400 mg placebo twice a day | Placebo comparator | Drug: Itacitinib PlaceboItacitinib 400 mg placebo twice a day |
| Itacitinib 100 mg twice a day | Experimental | Drug: ItacitinibThis dose group will be studied twice during the study. |
| Itacitinib 100 mg placebo twice a day | Placebo comparator | Drug: Itacitinib PlaceboThis dose group will be studied twice during the study. |
| Itacitinib 100mg once a day | Experimental | Drug: ItacitinibItacitinib 100mg once a day |
| Itacitinib 100 mg placebo once a day | Placebo comparator | Drug: Itacitinib PlaceboItacitinib 100 mg placebo once a day |
| Itacitinib 200 mg twice a day | Experimental | Drug: ItacitinibItacitinib 200 mg twice a day |
| Itacitinib 200 mg placebo twice a day | Placebo comparator | Drug: Itacitinib PlaceboItacitinib 200 mg placebo twice a day |
| Itacitinib 300 mg once a day | Experimental | Drug: ItacitinibItacitinib 300 mg once a day |
| Itacitinib 300 mg placebo once a day | Placebo comparator | Drug: Itacitinib PlaceboItacitinib 300 mg placebo once a day |
| Itacitinib 600 mg once a day | Experimental | Drug: ItacitinibItacitinib 600 mg once a day |
| Itacitinib 600 mg placebo once a day | Placebo comparator | Drug: Itacitinib PlaceboItacitinib 600 mg placebo once a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with active RA aged 18 to 75 years of age and meet tender and swollen joint assessment expectations defined in the study protocol.
- c-Reactive protein (CRP) or erythrocyte sedimentation rate (ESR) laboratory values meet minimal study protocol expectations.
Key exclusion criteria (5 listed)
- Females who are pregnant or breastfeeding.
- Men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.
- Subjects treated with a biologic agent within 12 weeks prior to first dose of study drug. (12 months in the case of rituximab.)
- Subjects with a history or currently suspected inflammatory disease other than RA.
- Subjects with a history of hematological disorders.
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 |
|---|---|---|
| ItacitinibAlso: INCB039110 | Drug | Itacitinib 100 mg twice a day, Itacitinib 100mg once a day, Itacitinib 200 mg twice a day, Itacitinib 300 mg once a day, Itacitinib 400 mg twice a day, Itacitinib 600 mg once a day |
| Itacitinib Placebo | Drug | Itacitinib 100 mg placebo once a day, Itacitinib 100 mg placebo twice a day, Itacitinib 200 mg placebo twice a day, Itacitinib 300 mg placebo once a day, Itacitinib 400 mg placebo twice a day, Itacitinib 600 mg placebo once a day |
Primary outcome
Safety and tolerability of itacitinib as assessed by the changes in frequency and severity of adverse events, ECGs, vital signs, physical examinations, and clinical laboratory evaluations.
Time frame: Approximately four months.
Preliminary efficacy as assessed by the percentage of patients achieving ACR20 improvement from baseline on the day 28 and day 84 visits.
Time frame: Approximately 84 days.
1 secondary outcome
Preliminary Pharmacokinetic (PK) collections.
Time frame: Following 15 days of therapy.
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 12 Mar 2019.
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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.
Victor Sandor, MD study director
Incyte Corporation
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itacitinib in people with Rheumatoid Arthritis, run by Incyte Corporation at 18 sites in 2 countries.
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 2 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 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and tolerability of itacitinib as assessed by the changes in frequency and severity of adverse events, ECGs, vital signs, physical examinations, and clinical laboratory evaluations. (time frame: Approximately four months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2019.