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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01790022
Other study ID # METALL 2012
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received February 9, 2013
Last updated February 9, 2013
Start date July 2012

Study information

Verified date February 2013
Source Saratov State Medical University
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Methylprednisolone


Locations

Country Name City State
Russian Federation Department of Rheumatology, Saratov Region Hospital Saratov

Sponsors (2)

Lead Sponsor Collaborator
Saratov State Medical University Charite University, Berlin, Germany

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
See also
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Completed NCT02186873 - A Study of Golimumab in Participants With Active Ankylosing Spondylitis Phase 3
Completed NCT01668004 - The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) Phase 4
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Completed NCT01934933 - Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis Phase 4
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