Pediatric Arthritis Study of Certolizumab Pegol

The overall study consists of a Screening Period of up to 4 weeks and an Open-Label Treatment
Period which will continue until the approval of the marketing application for the
Polyarticular-course Juvenile Idiopathic Arthritis (JIA) indication in the subject's country
or region or until further notice from UCB (approximately 4-6 years duration; depending on
region). A Final Visit will be conducted 12 weeks after last dose of study medication.
Overall, study visits will occur monthly during the first 6 months and every 2 months
afterwards. All patients will receive active treatment with Certolizumab Pegol. The dose will
depend on actual weight. Home dosing will be allowed between study visits.

If less than 50 % of the study population achieves an adequate response to the treatment
(American College of Rheumatology Pediatric 30 % (PedACR30) response) at Week 16, the study
will be entirely discontinued.

Inclusion Criteria:

- Onset of signs and symptoms consistent with a diagnosis of Juvenile Idiopathic
Arthritis (JIA) (according to the International League of Associations for
Rheumatology Classification of Juvenile Idiopathic Arthritis, 2001) and initiation of
JIA treatment for at least 6 months prior to Baseline (Active Polyarticular-course JIA
disease is defined as ≥ 5 joints with active Arthritis including: Polyarticular
Rheumatoid Factor (RF)-positive, Polyarticular RF-negative, extended oligoarticular,
Juvenile Psoriatic Arthritis and enthesitis-related Arthritis)

- Children and adolescents, aged 2 to 17 years (inclusive); weight ≥ 10 kg

- Inadequate response or intolerance to at least 1 Disease-Modifying Antirheumatic Drug
(DMARD) (previous exposure to a maximum of 2 biologic agents will be allowed)

- Methotrexate (MTX) and oral Corticosteroids will be allowed at stable doses prior to
Screening

- If not using Methotrexate (MTX), inadequate response or intolerance to MTX

Exclusion Criteria:

- History of systemic JIA, with or without systemic features

- Active Uveitis or a history of active Uveitis within the preceding 6 months

- Known history of Tuberculosis (TB), or high risk of acquiring TB and latent TB
infection; chronic, recurrent infection current sign or symptom which may indicate
infection, or at high risk of infection

- Viral Hepatitis or Human Immunodeficiency Virus (HIV) infection; live vaccination,
including attenuated, within defined period prior to study entry or during the study
(non-live vaccinations are permitted at any time prior to and during the study)

- The use of, or dose changes to, specific medications (eg, non-biologic DMARDs,
biologic DMARDs, oral and intramuscular/intravenous/intra-articular Corticosteroids)
will not be allowed for defined periods of time prior to study entry

- Previous exposure to Certolizumab Pegol (CZP), to more than 2 biologic DMARDs and
previous lack of response to more than 1 Tumor Necrosis Factor (TNFα) antagonist drug