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

Sponsor:	Schering-Plough
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 ]

Enrollment:	157
Study Start Date:	September 2009
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm A: Treatment Phase Infliximab plus naproxen during Treatment Phase	Drug: infliximab infusion Infliximab 5 mg/kg IV infusion on Week 0, 2, 6, 12, 18, and 24 Other Name: Remicade, SCH 215596 Drug: naproxen (Treatment Phase) Naproxen 500 to 1000 mg daily by mouth from Week 0 until Week 28 Other Name: Naprosyn
Placebo Comparator: Arm B: Treatment Phase 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 Other Name: Naprosyn
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 Other Name: Naprosyn
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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00844805 History of Changes
Other Study ID Numbers:	P05336, 2008-000982-51
Study First Received:	February 13, 2009
Last Updated:	October 13, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis
Naproxen
Infliximab
Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 09, 2012