Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Biopharma S.P.R.L.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject has active ankylosing spondylitis (AS), determined by documented radiologic evidence fulfilling the Modified New York criteria for AS including symptoms for \>=3 months and age of onset \<45 years
Subject has moderate to severe active disease as defined by each of the following:
1. BASDAI score \>=4
2. Spinal pain \>=4 on a 0 to 10 NRS (Numeric Rating Scale; from BASDAI item 2)
Subjects must have at least 1 of the following:
1. inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy
2. intolerance to administration of at least 1 NSAID
3. contraindication(s) to NSAID therapy
Subjects who are regularly taking NSAIDs/COX-2 inhibitors as part of their AS therapy are required to be on a stable dose for at least 14 days before Baseline
Subjects taking corticosteroids must be on an average daily dose of \<=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose up to Week 16
Subjects taking methotrexate (MTX) (\<=25mg/week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
Subjects taking sulfasalazine (up to 3grams/day) or hydroxychloroquine (up to 400mg per day total) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
Subjects may be tumor necrosis factor (TNF) inhibitor-naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:
1. experienced an inadequate response to previous treatment given for at least 12 weeks
2. been intolerant to administration (eg, had a side effect/adverse event that led to discontinuation)
3. lost access to TNF inhibitor for other reasons
You may not be if
Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis eg, rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus, or reactive arthritis
Subjects with any current sign or symptom that may indicate an active infection (except for the common cold)
Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
Subjects receiving any live vaccination within the 8 weeks prior to Baseline
Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection or current or history of nontuberculous mycobacteria (NTMB) infection
Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
1. \<= 3 excised or ablated basal cell carcinomas of the skin
2. One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
3. Actinic keratosis (-es)
4. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
