Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)

NCT00844805 | Completed Phase 3 Results

• 2 other identifiers: P053362008-000982-51
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study was to assess the proportion of participants in the infliximab plus naproxen arm versus the placebo plus naproxen arm, in a population of participants with moderate-to-severe active axial spondyloarthritis and disease duration of ≤3 years, who achieve the Assessment in Ankylosing Spondylitis (ASAS) partial remission criteria.

Conditions

Ankylosing Spondylitis; Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving the Assessment in Ankylosing Spondylitis (ASAS) Partial Remission Criteria at Week 28

  ASAS domains were measured on a visual analog scale (VAS) of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).

  Week 28

Secondary Outcomes (16)

• Number of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Follow-Up Phase

  Week 52

• Percentage of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Treatment Phase

  Week 52

• Change From Baseline of Berlin Magnetic Resonance Imaging (MRI) Spine Overall Score at Week 28

  Baseline, Week 28

• Change From Baseline in the Sacroiliac Overall Score at Week 28

  Baseline, Week 28

• Change From Baseline of Berlin MRI Spine Overall Score at Week 52

  Baseline, Week 52

Study Arms (4)

Infliximab + Naproxen

EXPERIMENTAL

Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.

Drug: Infliximab; Drug: Naproxen

Placebo + Naproxen

PLACEBO COMPARATOR

Placebo administered intravenously on Day 1 at Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.

Drug: Placebo; Drug: Naproxen

Naproxen Only (Follow-Up)

EXPERIMENTAL

For participants who achieved partial remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.

Drug: Naproxen

No Treatment (Follow-Up)

NO INTERVENTION

For participants who achieved partial remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.

Interventions

Infliximab DRUG

Also known as: Remicade, SCH 215596

Infliximab + Naproxen

Placebo DRUG

Placebo + Naproxen

Naproxen DRUG

Also known as: Naprosyn

Infliximab + Naproxen; Naproxen Only (Follow-Up); Placebo + Naproxen

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participant 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).

You may not qualify if:

• Participant 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (3)

• Sieper J, Lenaerts J, Wollenhaupt J, Rudwaleit M, Mazurov VI, Myasoutova L, Park S, Song Y, Yao R, Chitkara D, Vastesaeger N; All INFAST Investigators. Efficacy and safety of infliximab plus naproxen versus naproxen alone in patients with early, active axial spondyloarthritis: results from the double-blind, placebo-controlled INFAST study, Part 1. Ann Rheum Dis. 2014 Jan;73(1):101-7. doi: 10.1136/annrheumdis-2012-203201. Epub 2013 May 21.

  PMID: 23696633 RESULT

• Sieper J, Lenaerts J, Wollenhaupt J, Rudwaleit M, Mazurov VI, Myasoutova L, Park S, Song Y, Yao R, Chitkara D, Vastesaeger N; All INFAST Investigators. Maintenance of biologic-free remission with naproxen or no treatment in patients with early, active axial spondyloarthritis: results from a 6-month, randomised, open-label follow-up study, INFAST Part 2. Ann Rheum Dis. 2014 Jan;73(1):108-13. doi: 10.1136/annrheumdis-2013-203460. Epub 2013 Jun 5.

  PMID: 23740231 RESULT

• Poddubnyy D, Listing J, Sieper J. Brief Report: Course of Active Inflammatory and Fatty Lesions in Patients With Early Axial Spondyloarthritis Treated With Infliximab Plus Naproxen as Compared to Naproxen Alone: Results From the Infliximab As First Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial. Arthritis Rheumatol. 2016 Aug;68(8):1899-903. doi: 10.1002/art.39690.

  PMID: 27015283 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing; Axial Spondyloarthritis

Interventions

Infliximab; Naproxen

Condition Hierarchy (Ancestors)

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; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President,Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 12, 2017
• Results First Posted: December 17, 2012

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share