AzTrials
AzTrials

Psoriatic ArthritisPhase 2NCT02475304

Proof-of-concept Study of Forward Pharma (FP)187 in Patients With Mild/Moderate Psoriatic Arthritis

A Phase 2 study testing FP187 in people with Psoriatic Arthritis, run by Skane University Hospital at 1 site in Sweden.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of this study is to investigate, whether FP187 is effective in the treatment of mild to moderate psoriatic arthritis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
What is being tested?
FP187
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteSweden
Study dates
May 2015to Jun 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • documented clinical diagnosis of mild to moderate psoriatic arthritis of at least 3 months
  • active psoriatic arthritis with at least 2 tender and 2 swollen joints
  • signed informed consent
  • willingness and ability to comply with study procedures
  • besides psoriatic arthritis, patient must be in good general health in the opinion of the investigator, as determined by medical history, physical examination, vital signs, electrocardiography and clinical laboratory parameters
  • if patients are using methotrexate, they should be on a stable dosis of not more the 20mg per week for at least 90 days prior to study entrance and should present no serious toxic side effects attributable to methotrexate
  • female of childbearing age must be either surgically sterile or use a highly effective medically accepted contraceptive method

Who cannot join

  • female patients who are pregnant of breast-feeding or planning to become pregnant during the entire trial period
  • male patients planning pregnancy with their partner during the entire trial period, or practicing unprotected sexual relationship during the entire trial period
  • known allergy to any of the constituents of the products being tested
  • known immunosuppressive diseases (e.g. HIV, AIDS)
  • known history of latent or active granulomatous infection including tuberculosis, histoplasmosis or coccidioidomycosis
  • presence of another inflammatory disease including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematous or Lyme disease
Show all 22Show fewer
  • presence of chronic widespread pain syndrome
  • patients with pustular forms of psoriasis, erythrodermic or guttate psoriasis
  • patients with another non-psoriatic arthropathy (e.g. osteoarthritis)
  • presence of another serious or progressive disease including skin malignancy
  • presence or history of any malignancy (except for basal cell carcinoma, squamous cell carcinoma in situ of the skin treated with no evidence of recurrence within 5 years, or cervix cancer in situ treated with no evidence of recurrence.)
  • use at any time of an biological Disease Modifying Antirheumatic Drug (bDMARD) such as etanercept, adalimumab, golimumab, certolizumab pegol or infliximab
  • corticosteroid injections within 12 weeks
  • use of any dimethyl fumarate (DMF) containing product within 12 weeks
  • use of any retinoid treatments, other immunosuppressive treatments, cytostatics or drugs with known harmful effects on the kidneys within the last 3 months
  • use of cyclosporine, corticosteroids or psoralen + UVA (PUVA) treatment within 4 weeks
  • ongoing stomach or intestinal problems (e.g. gastritis or peptic ulcer)
  • Aspartate transaminase (AST) or Alanine transaminase (ALT) > 2x upper normal normal limit (UNL) or Gamma Glutamyl Transferase (gamma-GT) results >2.5 UNL
  • estimated creatinine clearance (Cockcroft-Gault) < 60ml/min
  • leucopenia (leucocyte count < 3.5/nl), eosinophilia (>750 / micro l) or lymphocytopenia (<1.02 / nl)
  • protein detected by urine stick test
  • participation in another clinical trial during the last 2 months or participation in a trial with another psoriatic arthritis treatment within 6 months

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Rheumatology, Skåne University Hospital

    Malmö, 20502

Other trials in Sweden

About this study

Official title: A Randomized, Double Blind, Placebo-controlled Proof-of-concept Study of FP187 in Patients With Mild to Moderate Psoriatic Arthritis

The purpose of this study is to investigate, whether FP187 is effective in the treatment of mild to moderate psoriatic arthritis.

Read the detailed description

The study is randomised, double blind, placebo-controlled proof-of-concept trial to investigate the efficacy and safety of FP187 compared to placebo over 24 weeks of treatment in patients with mild to moderate psoriatic arthritis (PsA). The daily dose levels in the FP187 arm will be 500 mg. After completion of the double blind treatment of 24 weeks, all patients irrespective of their treatment arm will be switched to an additional 24 week open-label treatment phase with 500 mg / day FP187. Patient who do not complete the 24 week double blind part of the study as scheduled will not be eligible for participation in the open-label part.

Being tested
FP187, Placebo
Medical subject headings
Arthritis, Psoriatic

What participants receive

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

  • FP187Drug

    Also called Dimethyl Fumarate

    FP 187 is given as oral tablets twice daily, 500 mg daily

  • PlaceboDrug

Study groups in NCT02475304
Study groupRoleWhat they receive
Experimental FP187ExperimentalTreatment with a daily dose of 500mg FP187 (twice daily). Other names: Dimethyl fumarate
Receives: Drug: FP187
Placebo ComparatorPlacebo comparatorPatients will receive the same number of tablets as patients randomized to FP187 arm in order to maintain the blind. The colour and shape of the FP187 and placebo tablets will be the same so that no visible difference is detectable
Receives: Drug: Placebo

What is being measured

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

  1. American Congress of Rheumatology (ACR)20

    Proportion of patients with a 20% improvement from baseline in tender/swollen joint counts according to the American College of Rheumatology criteria (ACR) based on a 66/68 joint count.

    Measured: Week 24

Secondary outcomes (10)

  1. ACR 20

    Proportion of patients with a 20% improvement from baseline in tender/swollen joint counts according to the American College of Rheumatology criteria (ACR) based on a 66/68 joint count.

    Measured: Weeks 8, 12, 28, 36, 40, 52

  2. BSA

    Body Surface Area (BSA) affected by psoriasis

    Measured: Weeks 8, 12, 24, 28, 36, 40, 52

  3. LEI

    Change from baseline in the Leeds Enthesitis Index (LEI)

    Measured: Weeks 8, 12, 24, 28, 36, 40, 52

  4. ACR 50

    Proportion of patients with a 50% improvement from baseline in tender/swollen joint counts according to the American College of Rheumatology criteria (ACR) based on a 66/68 joint count.

    Measured: Weeks 8, 12, 24, 28, 36, 40, 52

  5. ACR 70

    Proportion of patients with a 70% improvement from baseline in tender/swollen joint counts according to the American College of Rheumatology criteria (ACR) based on a 66/68 joint count.

    Measured: Weeks 8, 12, 24, 28, 36, 40, 52

  6. Pain

    Change from baseline in Pain Visual Analogue Scale (VAS) score

    Measured: Weeks 8, 12, 24, 28, 36, 40, 52

  7. EQ-5D

    Change from baseline in European Quality of Life - 5 Dimensions (EQ-5D) score

    Measured: Weeks 8, 12, 24, 28, 36, 40, 52

  8. BASDAI

    Change from baseline in Bath Ankylosing Spondylitis Disease Activity (BASDAI) score

    Measured: Weeks 8, 12, 24, 28, 36, 40, 52

  9. BASFI

    Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) score

    Measured: Weeks 8, 12, 24, 28, 36, 40, 52

  10. HAQ

    Change from baseline in Health Assessment Questionnaire (HAQ) score

    Measured: Weeks 8, 12, 24, 28, 36, 40, 52

Timeline

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

  1. First posted18 Jun 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionOct 2016
  4. Study completionJun 2017 (estimated)

Why it stopped: Difficulties to enrol patients

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02475304
Sponsor's protocol ID
PSA-201-DMF
Status last verified
Oct 2017
First submitted
31 May 2015
Last updated
5 Oct 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FP187 in people with Psoriatic Arthritis, run by Skane University Hospital at 1 site in Sweden.

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 22 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: withdrawn, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. 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 was withdrawn before enrolling participants, so there are no results.

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?

American Congress of Rheumatology (ACR)20 (time frame: Week 24). 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 NCT02475304.

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 5 Oct 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in