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

NCT01790022 | Unknown Phase 2

• 1 other identifier: METALL 2012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• The Assessment of Spondyloarthritis International Society 40 (ASAS40) response

  The Assessment of Spondyloarthritis International Society 40 (ASAS40) response is defined as an improvement of ≥40% and ≥2 points in at least 3 out of four following domains (and no worsening in remaining domain): * Patient global * Pain * Function (as measured by the Bath Ankylosing Spondylitis Functional Index - BASFI) * Inflammation (mean of the Bath Ankylosing Spondylitis Disease Activity Index - BASDAI question 5 and 6)

  Week 2

Study Arms (1)

Methylprednisolone 500 mg

EXPERIMENTAL

Methylprednisolone 500 mg administered intravenously at baseline

Drug: Methylprednisolone

Interventions

Methylprednisolone DRUG

Also known as: Metypred, Medrol, Solu-Medrol

Methylprednisolone 500 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saratov State Medical University: lead
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Department of Rheumatology, Saratov Region Hospital

Saratov, Russia

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Methylprednisolone; Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 9, 2013
• First Posted: February 12, 2013
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Last Updated: February 12, 2013

Record last verified: 2013-02

Locations

RU (1)