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

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

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.

Study Overview

• Status: Unknown
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Drug: Methylprednisolone

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Saratov, Russian Federation
    • Department of Rheumatology, Saratov Region Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Methylprednisolone 500 mg; Methylprednisolone 500 mg administered intravenously at baseline	Drug: Methylprednisolone; Other Names: Metypred, Medrol, Solu-Medrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Saratov State Medical University
• Collaborators: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ANTICIPATED): March 1, 2013

Study Registration Dates

• First Submitted: February 9, 2013
• First Submitted That Met QC Criteria: February 9, 2013
• First Posted (ESTIMATE): February 12, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 12, 2013
• Last Update Submitted That Met QC Criteria: February 9, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: METALL 2012