Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01790022
• Date of registration: 09/02/2013
• Prospective Registration: No
• Primary sponsor: Saratov State Medical University
• Public title: Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL) METALL
• Scientific 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
• Date of first enrolment: July 2012
• Target sample size: 20
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01790022
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Russian Federation

Key inclusion & exclusion 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) a
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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Methylprednisolone

Primary Outcome(s)

The Assessment of Spondyloarthritis International Society 40 (ASAS40) response [Time Frame: Week 2]

Secondary ID(s)

METALL 2012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Charite University, Berlin, Germany