Impact of Concomitant MTX on Efficacy, Safety and Adherence of Ustekinumab-treatment in Patients With Active PsA

Sponsor
Dr. Frank Behrens
Study ID
NCT03148860
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate — DRUG
    subjects will receive once weekly 15 mg (3 capsules) MTX
  • Ustekinumab — DRUG
    subject will receive Ustekinumab open-label over a treatment period of 52 weeks
  • Placebo — OTHER
    subjects will receive once weekly 3 capsules PLC to MTX

Study Details

Methotrexate (MTX) co-medication can improve the therapeutic effect of biological therapies (e.g. Tumor necrosis factor (TNF) -inhibitors) in rheumatoid arthritis (RA), but its role in Psoriatic Arthritis (PsA) remains unclear. No data from Randomized Clinical Trials (RCTs) are available to address the questions whether add-on of MTX to UST monotherapy, or a withdrawal of continuous MTX therapy in patients with newly initiated Ustekinumab (UST) treatment or simultaneously induction of MTX with UST in naive active PsA-patients will influence outcome measurements. So, the purpose of the study is to analyse the effects of blinded MTX-co-medication on outcome in patients treated with UST: Non-inferiority at week 24 of UST monotherapy compared to add-on to MTX in patients with active PsA and at least 12 weeks of MTX treatment prior to screening or who are actually not treated with MTX and do not have prior inadequate response to MTX-treatment for PsA will be demonstrated.

Key Dates

Start date
Dec 15, 2016
Status verified
Mar 2022
Primary completion
Apr 12, 2021
Completion
Oct 21, 2021

Study Design

Enrollment
186 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Methotrexate naive - Ustekinumab and Methotrexate
    Methotrexate naive subjects will be randomised to receive Methotrexate or Placebo, Ustekinumab will be given open-label
  • Placebo Comparator: Methotrexate naive - Ustekinumab and Placebo to Methotrexate
    Methotrexate naive subjects will be randomised to receive Methotrexate or Placebo, Ustekinumab will be given open-label
  • Active Comparator: Methotrexate pre-treated subjects-Ustekinumab and Methotrexate
    subjects pretreated with Methotrexate will be randomised to receive Methotrexate or Placebo, Ustekinumab will be given open-label
  • Placebo Comparator: Methotrexate pre-treated subjects-Ustekinumab and PLC
    subjects pretreated with Methotrexate will be randomised to receive Methotrexate or Placebo, Ustekinumab will be given open-label

Primary Outcome Measure

Assessment of mean values of DAS28 at week 24 [ Time Frame: week 24 ]

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