A randomized, double-blind, active control, multicenter study to evaluate the efficacy at week 52 of subcutaneously administered secukinumab monotherapy compared with subcutaneously administered adalimumab monotherapy in patients with active psoriatic arthritis

In PsA, more than half of the patients take biological DMARDs as a monotherapy
with very good control of their disease. Similar outcome in response has been
demonstrated with or without use of cDMARDs (including methotrexate). Thus no
biologics have shown positive synergistic effects on any clinical outcomes and
this is reflected in all their labels. Treatment with biologic monotherapy in
PsA is therefore clinically justifiable and avoids unwarranted exposure to the
potential toxicity of cDMARDs.
The randomized, double-blind, active control, multicenter, parallelgroup design
used in this study is in alignment with phase III trials of other biologics in
this disease area and also in compliance with the European Medicines Agency
(EMA) guidelines on PsA trials.

The purpose of this study is to compare the safety and efficacy of secukinumab
monotherapy and adalimumab monotherapy in patients with active psoriatic
arthritis (PsA) who are naïve to biologic therapy for PsA or PsO and are
intolerant or having inadequate response to conventional disease-modifying
antirheumatic drug (cDMARDs).
Efficacy will be evaluated based on multiple indices of improvement in signs
and symptoms, physical function, quality of life and patient reported outcomes.

This is a randomized, double-blind, active control, multicenter, parallel-group
trial evaluating secukinumab monotherapy and adalimumab monotherapy in
approximately 850 subjects with active PsA. A screening period of up to 8 weeks
before randomization will assess subject eligibility and be followed by a
treatment period of 52 weeks. Efficacy assessments will occur through Study
Week 52 and adverse event collection for safety will occur for an additional 16
weeks thereafter, at week 60 and 68. Total study duration is max 76 weeks.
At Baseline, subjects whose eligibility is confirmed will be randomized to
either Group 1 (secukinumab 300 mg as 2 x 150 mg s.c. injections), or Group 2
(adalimumab 40 mg as 1 s.c. injection) with approximately 425 subjects/group.
In order to maintain the blind, both groups will receive 1 or 2 placebo s.c.
injections to keep consistency in the number of injections at each dosing visit.
Secukinumab is available in 150 mg/1.0 mL pre-filled syringes (PFS) and
adalimumab is available in 0.4 mL PFS. Placebo (1.0 and 0.5 mL, PFS) is also
available.
Group 1 - Secukinumab 300 mg s.c.
Secukinumab 300 mg (2 x 1 mL PFS) will be administered at Baseline, Weeks 1, 2,
3 and 4, followed by dosing every 4 weeks until Week 48. In addition, all Group
1 subjects will receive placebo (1 x 1mL PFS) at given visits in order to
maintain the blind.
Group 2 - Adalimumab 40 mg s.c.
Adalimumab 40 mg (1 x 0.4 mL PFS) will be administered at Baseline followed by
dosing every 2 weeks until Week 50. In addition, all Group 2 subjects will
receive placebo (1 x 0.5mL or 2 x 0.5mL PFS) at given visits in order to
maintain the blind.

Investigational treatment:
- Secukinumab 150 mg, liquid formulation in a PFS (2 x 1 mL PFS for 300 mg dose)

Reference treatment:
- Adalimumab 40 mg, liquid formulation in a 0.4 mL PFS
- Placebo, liquid formulation in a 1 and 0.5 mL PFS

Adverse Events of Cosentyx or Humira
15x Physical examination (no internal investigations)
1x ECG
1x Chest X-ray
16x tender and swollen joint count
15x VAS scores for pain
15x VAS scores for disease activity (global and disease specific)
15x questionnaires (HAQ-DI, PAP, PGAD, PPAGDA)
8x questionnaires (DLQI, EQ-5D, FACIT, SF-36, WPAI-GH)
33 study visits (in case no home administration is performed) of 1 - 3 hrs,
depending on the amount of time needed to complete the questionnaires
17x blood draws (pain, bruising, a small blood cloth, infection at injection
site)
44 onderhuidse injecties met Cosentyx of Humira en placebo (pain, bleeding,
swelling, infection)
1x TB test (pain, swelling, hardness)