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

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ClinicalTrials.gov Identifier: NCT02475304
Recruitment Status : Withdrawn (Difficulties to enrol patients)
First Posted : June 18, 2015
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Elke Theander, Skane University Hospital

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

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: FP187 Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled Proof-of-concept Study of FP187 in Patients With Mild to Moderate Psoriatic Arthritis
Study Start Date : May 2015
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : June 2017


Arm Intervention/treatment
Experimental: Experimental FP187
Treatment with a daily dose of 500mg FP187 (twice daily). Other names: Dimethyl fumarate
Drug: FP187
FP 187 is given as oral tablets twice daily, 500 mg daily
Other Name: Dimethyl Fumarate

Placebo Comparator: Placebo Comparator
Patients 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
Drug: Placebo



Primary Outcome Measures :
  1. American Congress of Rheumatology (ACR)20 [ Time Frame: Week 24 ]
    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.


Secondary Outcome Measures :
  1. ACR 20 [ Time Frame: Weeks 8, 12, 28, 36, 40, 52 ]
    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.

  2. BSA [ Time Frame: Weeks 8, 12, 24, 28, 36, 40, 52 ]
    Body Surface Area (BSA) affected by psoriasis

  3. LEI [ Time Frame: Weeks 8, 12, 24, 28, 36, 40, 52 ]
    Change from baseline in the Leeds Enthesitis Index (LEI)

  4. ACR 50 [ Time Frame: Weeks 8, 12, 24, 28, 36, 40, 52 ]
    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.

  5. ACR 70 [ Time Frame: Weeks 8, 12, 24, 28, 36, 40, 52 ]
    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.

  6. Pain [ Time Frame: Weeks 8, 12, 24, 28, 36, 40, 52 ]
    Change from baseline in Pain Visual Analogue Scale (VAS) score

  7. EQ-5D [ Time Frame: Weeks 8, 12, 24, 28, 36, 40, 52 ]
    Change from baseline in European Quality of Life - 5 Dimensions (EQ-5D) score

  8. BASDAI [ Time Frame: Weeks 8, 12, 24, 28, 36, 40, 52 ]
    Change from baseline in Bath Ankylosing Spondylitis Disease Activity (BASDAI) score

  9. BASFI [ Time Frame: Weeks 8, 12, 24, 28, 36, 40, 52 ]
    Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) score

  10. HAQ [ Time Frame: Weeks 8, 12, 24, 28, 36, 40, 52 ]
    Change from baseline in Health Assessment Questionnaire (HAQ) score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475304


Locations
Sweden
Department of Rheumatology, Skåne University Hospital
Malmö, Sweden, 20502
Sponsors and Collaborators
Skane University Hospital
Investigators
Principal Investigator: Elke Theander, MD. PhD Skåne University Hospital, Lund University, 20502 Malmö, Sweden

Responsible Party: Elke Theander, senior consultant Rheumatology, associate professor, PhD, Skane University Hospital
ClinicalTrials.gov Identifier: NCT02475304     History of Changes
Other Study ID Numbers: PSA-201-DMF
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs