Infliximab for Treatment of Axial Spondyloarthritis (Study P05336AM1) - Full Text View

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00844805

Purpose

This trial will enroll patients with active axial spondyloarthritis of less than 3 years duration.

In the first part of this trial, patients who qualify will be randomized to receive either infliximab plus naproxen or placebo plus naproxen. Patients will attend scheduled office visits to be medically evaluated for treatment progress (drug effectiveness, safety, disease progression). After 28 weeks of treatment, the primary assessment will be performed to determine whether or not more patients are in partial remission with infliximab versus placebo.

In the second part of this trial, patients who are in remission from the first part of this trial will be followed-up for approximately 6 more months. Patients will be randomized to either continue naproxen or to discontinue naproxen. Patients will attend scheduled office visits and be monitored for disease flare ups during this time.

Condition	Intervention	Phase
Ankylosing Spondylitis Axial Spondyloarthritis	Drug: infliximab infusion Drug: placebo infusion Drug: naproxen (Treatment Phase) Drug: naproxen (Follow-Up Phase) Other: no intervention (Follow-Up Phase)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial

Resource links provided by NLM:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Drug Information available for: Naproxen Naproxen sodium Infliximab

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Proportion of subjects in each study arm (Arm A and Arm B) meeting the ASAS partial remission criteria at Week 28. [ Time Frame: At week 28 ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	September 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Treatment Phase: Experimental Infliximab plus naproxen during Treatment Phase	Drug: infliximab infusion Infliximab 5 mg/kg IV infusion on Week 0, 2, 6, 12, 18, and 24 Drug: naproxen (Treatment Phase) Naproxen 500 to 1000 mg daily by mouth from Week 0 until Week 28
Arm B: Treatment Phase: Placebo Comparator Placebo plus naproxen during Treatment Phase	Drug: placebo infusion PLACEBO IV infusion on Week 0, 2, 6, 12, 18, and 24 Drug: naproxen (Treatment Phase) Naproxen 500 to 1000 mg daily by mouth from Week 0 until Week 28
Arm C For those who achieved remission during Treatment phase, naproxen will be continued for patients randomized into Arm C. The Follow-Up phase is not blinded.	Drug: naproxen (Follow-Up Phase) Naproxen 500 to 1000 mg daily by mouth from Week 28 until Week 52 or Early Termination
Arm D For those who achieved remission during Treatment phase, naproxen will be discontinued for patients randomized into Arm D. The Follow-Up phase is not blinded.	Other: no intervention (Follow-Up Phase) Subjects in this arm will discontinue naprosyn and continue Follow-Up phase.

Eligibility

Ages Eligible for Study:	18 Years to 48 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject must:

be 18 to 48 years of age
have diagnosis of active axial spondyloarthritis, with disease duration of less than or equal to 3 years.
have active disease during trial enrollment
have limited treatment history for axial spondyloarthritis (must meet certain criteria)
agree to an acceptable method of contraception (for women of childbearing potential and all men)
must meet certain tuberculosis screening requirements
must meet certain laboratory screening safety requirements
have an x-ray of the sacroiliac joints available from within the previous 12 months (or have one performed during the Screening visit if site is outside of Germany).

Exclusion Criteria:

Subjects will be excluded:

for certain medical conditions and/or recent history of certain medical disorders
for current or recent treatment with certain other medications and certain vaccinations.
for being a woman who is breastfeeding, pregnant, or intending to become pregnant.
if known to have had a substance abuse problem within the previous 3 years prior to screening.
if currently participating in any other clinical study.
for other administrative reasons.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844805

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Austria
Investigational Site 17	Recruiting
Vienna, Austria, A-1130
Russian Federation
Investigational Site 22	Recruiting
St.-Petersburg, Russian Federation, 191015
Investigational Site 23	Recruiting
Moscow, Russian Federation, 115522
Investigational Site 28	Recruiting
Tula, Russian Federation, 300053
Investigational Site 25	Recruiting
Kazan, Russian Federation, 420103
Investigational Site 26	Recruiting
Yaroslavl, Russian Federation, 150030
Investigational Site 24	Recruiting
St.-Petersburg, Russian Federation, 190068

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05336, 2008-000982-51
Study First Received:	February 13, 2009
Last Updated:	February 8, 2010
ClinicalTrials.gov Identifier:	NCT00844805 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Infliximab
Physiological Effects of Drugs
Infection
Bone Diseases
Gout Suppressants
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Spondylitis, Ankylosing
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Dermatologic Agents

Spondylarthritis
Spondylitis
Ankylosis
Spondylarthropathies
Spinal Diseases
Naproxen
Joint Diseases
Cyclooxygenase Inhibitors
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions
Bone Diseases, Infectious
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 08, 2010