A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED)

NCT00779012 | Completed Phase 4

• 1 other identifier: P04042
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to prove reasonability of registration in Russian federation this new indication (ankylosing spondylitis \[AS\]) through evaluation of safety and efficacy rate of Remicade 5mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions).

Conditions

Spondylitis, Ankylosing

Outcome Measures

Primary Outcomes (1)

• Evaluation of the efficacy and safety rate of the study drug, Remicade, in decreasing symptoms and signs of AS (pain) as well as the evaluation of the safety and the tolerance of the profile of the drug.

  The patient undergoes the complex evaluation of the articular status every 6 -8 weeks.

Secondary Outcomes (18)

• Frequency of achievement of at least 50% ASAS improvement (compared to baseline) 8 weeks after the last infusion of Remicade.

  8 weeks after the last infusion of Remicade

• Frequency of at least 50% of the stable improvement of ASAS (compared to baseline) over a period of the supportive treatment phase (after infusion 3, up to 6 to 8 weeks after the last infusion of Remicade)

  Up to 8 weeks after the last infusion of Remicade

• Frequency of at least 20%, 50%, and 75% of ASAS improvement (compared to baseline) 6 to 8 weeks after the last infusion of Remicade

  Up to 8 weeks after the last infusion of Remicade

• Change in AS activity (BASDAI) compared to baseline 6 to 8 weeks after the last infusion of Remicade

  Up to 8 weeks after the last infusion of Remicade

• Change of global evaluation of the activity of the disease by patient (VAS) compared to baseline 6 to 8 weeks after the last infusion of Remicade

  Up to 8 weeks after the last infusion of Remicade

Study Arms (1)

Remicade

EXPERIMENTAL

Biological: Infliximab

Interventions

Infliximab BIOLOGICAL

Remicade 5 mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions).

Also known as: Remicade, SCH 215596

Remicade

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 to 70 years of age.
• Males and female patients of reproductive potential (also includes women who have been postmenopaused \<1 year) must use a reliable birth control method (abstinence, oral contraceptives, diaphragm prescribed by a physician, condom used with a spermicide, surgical sterilization) up until 6 months after the last Remicade infusion.
• Proven AS according to the modified New York criteria implying that included patients must have a pelvic x-ray showing the signs of sacroiliitis \> grade 2 bilateral.
• Ability to comprehend the terms of the participation in the study, willing to follow all procedures and instructions and informed consent form signed before the beginning of the first procedures of the study (except several cases of chest x-ray).
• Screening for prevention of latent and active TB must be performed according to the local guidelines and/or the current SPC and alert card. This will include a PPD test and a Chest x-ray to be performed within 30 days prior to initiating treatment with Remicade.

You may not qualify if:

• Pregnant women, nursing mothers or a planned pregnancy within 6 months after the last infusion.
• Patients who have any concurrent systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from Remicade, e.g. Lyme disease, or a rheumatic disease (lupus erythematosus, systemic scleroderma) with the joint affection and sacroileitis.
• Prior administration of Remicade or any other therapeutic agent targeted at reducing TNF (e.g.,Etanercept, pentoxifylline, thalidomide or anti-CD4+ antibody) within the previous 3 months.
• History of known allergies to murine proteins.
• Any chronic infections in the acute phase, e.g. upper respiratory tract infections or other localization (chronic bronchitis, pneumonia, pyelonephritis, cholecystitis, hepatitis etc.).
• Documented HIV infection.
• Positive hepatitis B and C test without clinical signs of the disease.
• Current skin psoriasis, nonspecific ulcerative colitis and Crohn's disease.
• History of opportunistic infections such as herpes zoster within 2 months of screening. Evidence of active CMV, active pneumocystis carinii, drug resistant atypical mycobacterium infections, etc.
• Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease.
• Any currently known malignancy or pre-malignant lesions or any history of malignancy within the past 5 years.
• Active and/or latent TB or previous history of TB.
• Supportive prednisone therapy \>10 mg/day.
• Patients with moderate or severe heart failure (NYHA class III/IV).
• Septic arthritis (or infected joint implant) within at least last 12 months.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Bunchuk NV, Rumiantseva OA, Loginova EIu, Bochkova AG, Storozhakov GI, Ettinger OA, Kosiura SD, Kamalova RG, Valishina LM. [The efficacy and safety of infliximab in patients with ankylosing spondylitis: results of an open-labeled multicenter study]. Ter Arkh. 2010;82(10):41-6. Russian.

  PMID: 21341463 RESULT

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Infliximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: October 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 11, 2017

Record last verified: 2017-05