Clinical Trials Logo

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
  Status Clinical Trial Phase
Terminated NCT02685904 - A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis Phase 3
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
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Completed NCT01934933 - Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis Phase 4
Not yet recruiting NCT04875299 - Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients
Completed NCT02758782 - NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis Phase 4
Completed NCT02763111 - Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis Phase 2
Active, not recruiting NCT02687620 - Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Completed NCT01750528 - Prevalence and Progression of Periodontitis in Ankylosing Spondylitis N/A
Completed NCT01463189 - Web-based Support to Manage Arthritis Pain Phase 2
Completed NCT01091675 - Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs Phase 3
Completed NCT00844805 - Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) Phase 3
Recruiting NCT00747578 - Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan N/A
Completed NCT01083693 - Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs N/A
Completed NCT00715091 - Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis Phase 4
Not yet recruiting NCT00517101 - Presence of IBD Specific Antibodies (ASCA, ALCA, ACCA, AMCA) in the Sera of Patients With Spondyloarthropathy N/A
Completed NCT00367211 - Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. Phase 3
Completed NCT00133315 - TNFalfa Blocking Treatment of Spondylarthropathies Phase 4