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Phosphodiesterase 4 (PDE4) Inhibitor

Apremilast (CC-10004) for Psoriatic Arthritis (FOREMOST Trial)

Phase 4
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights

FOREMOST Trial Summary

This trial will test a drug called apremilast to see if it is safe and effective in reducing symptoms of psoriatic arthritis in people who have had the disease for less than 5 years.

Eligible Conditions
  • Psoriatic Arthritis

FOREMOST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Achieved a Clinical State of Minimal Disease Activity (MDA-Joints) Response at Week 16
Secondary outcome measures
Change From Baseline in Psoriatic Arthritis Impact of Disease 12-item for Clinical Trials (PsAID-12) Questionnaire Score at Week 16
Percentage of Participants Who Achieved Remission or Low Disease Activity at Week 16 Based on Clinical Activity in Psoriatic Arthritis (cDAPSA)
Percentage of Participants With Patient's Global Assessments of Disease Activity Score of ≤ 20 mm in the VAS at Week 16
+4 more

FOREMOST Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Apremilast 30 mg twice daily ± NSAIDs, ≤ 1 csDMARDExperimental Treatment1 Intervention
Subjects will take ORAL tables of apremilast for up to 48 weeks (30 mg twice daily). Subjects may also receive stable doses of background therapy (standard or care) with NSAIDs, glucorticosteroids and 1 csDMARD as permitted by protocol. After wk. 24, subjects may change the dose /type of permitted Psoriatic Arthritis medications
Group II: PlaceboPlacebo Group1 Intervention
Subjects will take placebo for up to 24 weeks (twice daily). Subjects may also receive stable doses of background therapy ( standard of care) with NSAIDs, glucocorticosteroids and 1 csDMARD as permitted by protocol. After wk 24, subjects may change the dose /type of permitted PsA medications.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apremilast (CC-10004)
2018
Completed Phase 4
~430

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,371 Previous Clinical Trials
1,377,796 Total Patients Enrolled
22 Trials studying Psoriatic Arthritis
99,233 Patients Enrolled for Psoriatic Arthritis
MDStudy DirectorAmgen
914 Previous Clinical Trials
924,269 Total Patients Enrolled
16 Trials studying Psoriatic Arthritis
5,449 Patients Enrolled for Psoriatic Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare sites in North America have this trial underway?

"Across the United States, 56 clinical sites are offering this medical trial. Prominent cities with locations include Philadelphia, Beckley and Providence. Patients should seek out the closest site to them in order to minimize transportation needs if they decide to participate."

Answered by AI

To what degree has CC-10004 been proven safe for individuals?

"There is existing clinical evidence that backs the safety of Apremilast (CC-10004), so it received a rating of 3."

Answered by AI

How many people have enrolled in the trial to date?

"Unfortunately, this trial is no longer enrolling patients. The study was first listed on December 31st 2018 and the details were last updated on November 28th 2022. If you are researching alternative trials, there are currently 372 studies for arthritis sufferers actively accepting participants as well 13 clinical trials involving Apremilast (CC-10004) in need of volunteers."

Answered by AI

What research has been performed to assess the efficacy of Apremilast (CC-10004)?

"Apremilast (CC-10004) was first studied in 2014 at Attikon Hospital. To date, 76 clinical trials have been concluded and 13 are still active; these experiments mainly take place around Philadelphia, Pennsylvania."

Answered by AI

Does this experiment currently have open enrollment?

"No longer accepting participants, this research initiative was first published on December 31st 2018 and the most recent update being made on November 28th 2022. Those searching for other similar studies might consider 372 trials involving arthritis and psoriatic patients or 13 Apremilast (CC-10004) clinical experiments still recruiting individuals."

Answered by AI

What medical conditions could Apremilast (CC-10004) potentially benefit?

"Apremilast (CC-10004) not only has the capacity to heal ulcers, but is also leveraged for treating chronic skin conditions such as psoriasis, behcet's syndrome, and severe plaque psoriasis."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
How old are they?
18 - 65
What site did they apply to?
Manitoba Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have been on sulphasalazine since June 2019 1500 mg bid, methotrexate 25mg has been added since mid Oct 2022.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

does this study involve placebos? how many times do I have to travel to Winnipeg? Are travel expenses partially covered?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. Manitoba Clinic: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
2018. "Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03747939.
~50 spots leftby Apr 2025
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