A multicenter, open-label (Part A) followed by a randomized, double-blind, parallel-group, placebo controlled study (Part B) to evaluate maintenance of remission in subjects with active axial spondyloarthritis (axSpA) receiving either Certolizumab pegol 200mg Q2W or 200mg Q4W as compared to placebo

Axial Spondyloarthritis (axSpA) is a chronic inflammatory disease. This is a
type of rheumatic disorders that impacts a substantial proportion of the
population. The majority of patients with axSpA have back pain due to
inflammation. The most characteristic feature of axSpA is the formation of new
bone that ultimately leads to a fusion of the spine. Axial SpA typically
presents in patients younger than 45 years of age. Unfortunately, many patients
are diagnosed in a late stage of this disease when fusion of the sacroiliac
joints (where your lower back meets with your pelvis) and maybe even the spine
has already progressed significantly. In this study patients with an early
disease stage (axSpA) and progressed stage (AS * Ankylosing Spondylitis) will
be treated with an anti-inflammatory drug named Certolizumab pegol, with the
aim to achieve a significant improvement of the health status of axSpA and AS
patients and to demonstrate that the improved health status can be maintained
after reduction or even withdrawal of the study drug.

The primary objective of the study is to evaluate the percentage of subjects
who do not experience a flare on CZP 200mg Q2W (full-dose) or 200mg Q4W
(half-dose) during Part B. The secondary objectives are: 1) to evaluate the
percentage of subjects achieving sustained remission at the end of Part A, 2)
to evaluate the time to flare and other measures of signs and symptoms, to
compare the percentage of subjects who do not experience a flare between
CZP full-dose and half-dose, and to evaluate the efficacy of re-initiation of
treatment with the CZP full-dose in subjects who experience a flare following a
withdrawal or dose reduction of CZP for subjects randomized into Part B, 3) to
assess safety and tolerability of CZP, and 4) to evaluate inflammatory changes
over time as assessed by magnetic resonance imaging (MRI).

Study AS0005 is a multicenter, open-label (Part A) followed by a randomized,
double-blind, parallel-group, placebo-controlled clinical study (Part B) to
evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of
certolizumab pegol (CZP) in adult subjects with active axial spondyloarthritis
(axSpA) in sustained remission who continued either on full-dose treatment (CZP
200mg every 2 weeks [Q2W]), on a dose reduction (CZP 200mg every 4 weeks [Q4W])
or withdrawal of CZP treatment. The study includes 2 parts: an Open-Label
Run-In Period for 48 weeks (Part A) followed by a Double-Blind Period for 48
weeks (Part B) with
3 treatment arms (200mg CZP Q2W [referred to as full-dose], 200mg CZP Q4W
[referred to as half-dose], and placebo), and a Safety Follow-Up (SFU) Period
for 10 weeks after the last dose of study medication.

Eligible subjects will receive
3 loading doses of CZP 400mg subcutaneous (sc) at Weeks 0 (Baseline), 2, and 4
followed by CZP 200mg Q2W in Period 2 from Week 6 to Week 46.
Subjects in sustained remission at the end of Part A will be randomized in a
1:1:1 ratio to the following treatment arms: 1) CZP administered sc at a dose
of 200mg Q2W (full-dose), 2) CZP administered sc at a dose of 200mg Q4W
(half-dose), and 3) placebo.

For the patient the extra burden is mostly the tests to keep checking the
health, and the question lists also for health and wellbeing.
Also because of this the patient will be monitored well for possible side
effects of the medication and/or procedures (injections).
the results of this study will be important for the treatment of this type of
patients.