A Study of Golimumab in Participants With Active Ankylosing Spondylitis

This is a Phase 3, multicenter (when more than one hospital or medical school team work on a
medical research study), randomized (study drug assigned by chance), double-blind (neither
the researchers nor the participants know what treatment the participant is receiving),
placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is
compared in a clinical trial with a drug to test if the drug has a real effect) study of
golimumab compared with placebo in participants with active ankylosing spondylitis. The study
comprises of 4 phases: Screening phase (up to 6 weeks), Double-blind placebo-controlled phase
(Week 0 to Week 16), Active treatment phase (Week 16 to Week 52), and Safety follow-up phase
(8 weeks from last study drug administration). Total duration of the study will be 60 weeks
per participant. Eligible Participants will be randomly assigned to either Treatment group 1:
Placebo or Treatment group 2: Golimumab. Participants randomized to Placebo group, will
receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants
receiving placebo will begin receiving intravenous infusions of golimumab (2 mg/kg) at Weeks
16, 20 and thereafter every 8 weeks up to Week 52. Participants randomized to Golimumab
group, will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter
every 8 weeks up to Week 52. At Week 16, participants randomized to golimumab group will
receive a placebo infusion to maintain the blind. The efficacy will be assessed primarily by
measuring percentage of participants who achieve a 20 percent improvement from baseline in
the assessment in ankylosing spondylitis (ASAS) at Week 16. Participant's safety will be
monitored throughout the study.

Inclusion Criteria:

- Participants with diagnosis of definite ankylosing spondylitis for at least 3 months
based on modified New York radiographic and clinical criteria

- Participants with symptoms of active disease at screening and at baseline

- Participant has either an inadequate response to at least 2 non-steroidal
anti-inflammatory drugs (NSAID) over a 4 week period in total with maximal recommended
doses of NSAIDs, or is unable to receive a full 4 weeks of maximal NSAID therapy
because of intolerance, toxicity, or contraindications to NSAIDs

- Participants with C- reactive protein (CRP) level of greater than or equal to (>=) 0.3
milligram per deciliter (mg/dL) at screening

- Additional protocol-defined inclusion criteria apply

Exclusion Criteria:

- Participant with other inflammatory diseases that might confound the evaluations of
benefit from the golimumab therapy

- Pregnant or lactating females

- Participants with chest radiograph within 3 months prior to the first administration
of study agent that shows an abnormality suggestive of a malignancy or current active
infection, including tuberculosis

- Participants who had a serious infection (including but not limited to, hepatitis,
pneumonia, sepsis, or pyelonephritis), or have been hospitalized for an infection, or
have been treated with intravenous (IV) antibiotics for an infection within 2 months
prior to first administration of study agent

- Additional protocol-defined exclusion criteria apply