Clinical trial NCT01790022: Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL)
Official title: Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL) - a 12-week, Prospective, Open-label, Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Lead sponsor: Saratov State Medical University
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
First posted: 2013-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, efficacy of methylprednisolone in reduction of signs and symptoms (back pain, stiffness, joint pain and swelling) of active ankylosing spondylitis (AS) will be investigated. It is expected, that a single dose of methylprednisolone 500 mg given intravenously at baseline will lead to a rapid reduction of symptoms of active AS, which can be seen already 2 weeks after drug administration.


Eligibility criteria: Inclusion Criteria:

* Age of ≥18 years.
* Definite diagnosis of AS according to the modified New York criteria.
* History of an inadequate response to ≥2 nonsteroidal antiinflammatory drugs (NSAIDs) taken for at least 2 weeks each or NSAIDs intolerance.
* Active disease as defined by the Bath Ankylosing Spondylitis DIsease Activity Index (BASDAI) value of ≥4 at screening despite concomitant treatment with an NSAID or without NSAIDs in case of intolerance.

Exclusion Criteria:

* The female subject is pregnant or lactating.
* Patients with other chronic inflammatory articular disease or systemic autoimmune disease.
* History of inadequate response to previous anti-tumour necrosis factor (TNF) α therapy.
* Treatment with any other investigational drug within 4 weeks of 5 half-life of the drug (whichever is longer) prior to baseline.
* Treatments with disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate within 4 weeks prior to screening (8 weeks for leflunomide or 4 weeks with a standard cholestyramine wash-out).
* Treatment with intravenous, intramuscular or intraarticular/periarticular steroids within 4 weeks prior to screening.
* History of oesophageal, gastric, duodenal or intestinal ulceration, clinically relevant gastrointestinal bleeding.
* History of or current signs of coronary heart disease, myocardial infarction, stroke or transient ischemic attack, peripheral arterial thrombotic events.
* Congestive heart failure (NYHA III-IV)
* Uncontrolled arterial hypertension.
* History of diabetes mellitus.
* History of glaucoma.
* Major surgery within 12 weeks prior to screening.
* Evidence of any other severe uncontrolled gastrointestinal, hepatic, renal, pulmonary, cardiovascular, nervous or endocrine disorders.
* Any active current viral, bacterial or fungal infection, a history of recurrent clinically significant infection, infections requiring treatment with antibiotics within 4 weeks prior to baseline.
* History of chronic infection with hepatitis B or C, history of HIV infection.
* Primary or secondary immunodeficiency.
* Any other conditions making the patient unsuitable in the opinion of the investigator for the participation in the current study.

Primary outcomes:
measure: The Assessment of Spondyloarthritis International Society 40 (ASAS40) response
timeFrame: Week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Saratov
country: Russian Federation
facility: Department of Rheumatology, Saratov Region Hospital
Study officials:
References: