Rheumatoid ArthritisPhase 2NCT00550043

A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis

A Phase 2 study testing INCB018424 in people with Rheumatoid Arthritis, run by Incyte Corporation at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: INCB018424
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 15 sitesin 2 countries
Study dates: Oct 2007to Sep 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Established diagnosis of rheumatoid arthritis
Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry.

Who cannot join

Patients who have taken the following drugs within the timeframe below:
Leflunomide, infliximab, etanercept, adalimumab, abatacept, or other biological therapies (except rituximab) - Within 12 weeks prior to the first dose of study medication;
Rituximab - Within 12 months prior to the first dose of study medication;
Disease-modifying anti-rheumatic drugs (DMARDs) or other anti-rheumatic therapies not specified above including but not limited to: gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil - Within 12 weeks prior to the first dose of study medication;
Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.

Trial locations and contacts

15 sites in 2 countries.

Country

City, postcode or hospital

15 sites in 2 countries

United States12 sites

Study site
Gainesville, Florida, 32607
Study site
Hickory, North Carolina, 28601
Study site
Hixson, Tennessee, 37343
Study site
Huntsville, Alabama, 35801
Study site
Kalispell, Montana, 59901
Study site
Mayfield Village,, Ohio, 44143
Study site
Memphis, Tennessee, 38119
Study site
Middleburg Heights, Ohio, 44130
Study site
Palm Harbor, Florida, 34684
Study site
Perrysburg, Ohio, 43551
Study site
Pittsburgh, Pennsylvania, 15261
Study site
Upland, California, 91786

Other trials in United States

Poland3 sites

Study site
Elblag
Study site
Gmina Końskie
Study site
Warsaw

Other trials in Poland

About this study

Official title: A Double-blind, Placebo-controlled Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis

The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis
Being tested: INCB018424, Placebo
Keywords: Rheumatoid arthritis
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INCB018424Drug
PlaceboDrug

Study groups in NCT00550043
Study group	Role	What they receive
Cohort 1: Treatment Group A	Experimental	INCB018424 15 mg twice daily (BID) or matching placebo Receives: Drug: INCB018424
Cohort 2: Treatment Group B	Experimental	INCB018424 5 mg BID or matching placebo Receives: Drug: INCB018424
Cohort 2: Treatment Group C	Experimental	INCB018424 25 mg BID or matching placebo Receives: Drug: INCB018424
Cohort 2: Treatment Group D	Experimental	INCB018424 50 mg once daily (QD) or matching placebo Receives: Drug: INCB018424
Placebo	Placebo comparator	Matching placebo, oral Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement
The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: subject's assessment of pain, Subject's global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), subject's self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
Measured: Day 28

Secondary outcomes (8)

The Percentage of Subjects Achieving ACR 50 Improvement
The ACR 50 is defined as ≥ 50% improvement in tender joint count plus ≥ 50% improvement in swollen joint count plus ≥50% improvement in 3 of the following 5 criteria: subject's assessment of pain, PGA, PHGA, subject's self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.
Measured: Day 28
The Percentage of Subjects Achieving ACR 70 Improvement
The ACR 70 is defined as ≥ 70% improvement in tender joint count plus
≥ 70% improvement in swollen joint count plus ≥ 70% improvement in 3 of the following 5 criteria: subject's assessment of pain, PGA, PHGA, subject's self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.
Measured: Day 28
Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score
Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus Erythrocyte sedimentation rate (ESR). The DAS28-ESR is expressed as units on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6. The mean change from baseline (which represent decreases in the DAS 28 ESR scores) are shown as positive numbers in these analyses.
Measured: Baseline, Day 28
Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score
Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus C-reactive protein (CRP). A higher score indicated more disease activity. The mean change from baseline (which represent decreases in the DAS 28 CRP scores) are shown as positive numbers in these analyses. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).
Measured: Baseline, Day 28
Percentage of Subjects Who Achieved DAS 28 ESR Low Disease
Subjects who achieved low disease activity based on the DAS 28 ESR (score <3.2). Subjects who achieved low disease activity were classified as responders in this analysis.
Measured: Day 28
Percentage of Subjects Who Achieved DAS 28 CRP Low Disease
Subjects who achieved low disease activity based on the DAS 28 CRP (score <3.2). Subjects who achieved low disease activity were classified as responders in this analysis.
Measured: Day 28
Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease
Subjects who achieved inactive disease based on the DAS 28 ESR (score <2.6). Subjects who achieved low disease activity were classified as responders in this analysis.
Measured: Day 28
Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease
Subjects who achieved inactive disease based on DAS 28 CRP (score <2.6). Subjects who achieved low disease activity were classified as responders in this analysis.
Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Sep 2008

First posted26 Oct 2007 (estimated)
Study startOct 2007
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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, Care provider, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00550043
Sponsor's protocol ID: INCB 18424-231
Status last verified: Mar 2015
First submitted: 24 Oct 2007
Last updated: 23 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2015. 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 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT00550043
Acronym / sponsor ID: INCB 18424-231
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 26 Oct 2007 (estimated)
Results: Posted 23 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
Cohort 1: Treatment Group A	Experimental	Drug: INCB018424INCB018424 15 mg twice daily (BID) or matching placebo
Cohort 2: Treatment Group B	Experimental	Drug: INCB018424INCB018424 5 mg BID or matching placebo
Cohort 2: Treatment Group C	Experimental	Drug: INCB018424INCB018424 25 mg BID or matching placebo
Cohort 2: Treatment Group D	Experimental	Drug: INCB018424INCB018424 50 mg once daily (QD) or matching placebo
Placebo	Placebo comparator	Drug: PlaceboMatching placebo, oral

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Established diagnosis of rheumatoid arthritis
Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry.

Key exclusion criteria (5 listed)

Patients who have taken the following drugs within the timeframe below:
Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.

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
INCB018424	Drug	Cohort 1: Treatment Group A, Cohort 2: Treatment Group B, Cohort 2: Treatment Group C, Cohort 2: Treatment Group D
Placebo	Drug	Placebo

Primary outcome

The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement
Time frame: Day 28
The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: subject's assessment of pain, Subject's global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), subject's self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.

8 secondary outcomes

The Percentage of Subjects Achieving ACR 50 Improvement
Time frame: Day 28
The Percentage of Subjects Achieving ACR 70 Improvement
Time frame: Day 28
Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score
Time frame: Baseline, Day 28
Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score
Time frame: Baseline, Day 28
Percentage of Subjects Who Achieved DAS 28 ESR Low Disease
Time frame: Day 28
Percentage of Subjects Who Achieved DAS 28 CRP Low Disease
Time frame: Day 28
Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease
Time frame: Day 28
Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease
Time frame: Day 28

Results and safety

Results posted to the registry on 23 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	9	9
Cohort 1: Treatment Group A	12	9
Cohort 2: Treatment Group B	9	8
Cohort 2: Treatment Group C	10	8
Cohort 2: Treatment Group D	10	9

Primary outcome: The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement

Time frame: Day 28. Number. Unit: Percentage of participants

Measure	Placebo n = 9	Cohort 1: Treatment Group A n = 12	Cohort 2: Treatment Group B n = 9	Cohort 2: Treatment Group C n = 10	Cohort 2: Treatment Group D n = 10
No Response	66.7	16.7	66.7	40.0	40.0
Response	33.3	83.3	33.3	60.0	60.0

Population analysed: modified intent-to-treat (mITT) Population: subjects enrolled, took 1 dose of study drug, had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects discontinuing before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time the subject ingested the first dose of study drug up to 28 days after the last dose of study drug was administered.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
Cohort 1: Treatment Group A	0 of 12 (0%)	6 of 12 (50%)	Not reported
Cohort 2: Treatment Group B	0 of 9 (0%)	2 of 9 (22.2%)	Not reported
Cohort 2: Treatment Group C	0 of 10 (0%)	6 of 10 (60%)	Not reported
Cohort 2: Treatment Group D	1 of 10 (10%)	7 of 10 (70%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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.

Monica Luchi, MD study director

Incyte Corporation

15 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 INCB018424 in people with Rheumatoid Arthritis, run by Incyte Corporation at 15 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 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Poland. 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?

Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement (time frame: Day 28). 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 NCT00550043.

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 23 Mar 2015.