Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451)

Hip Arthritis Associated With AS Efficacy and Safety of Early Treatment With Infliximab (Remicade®)

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01148901

Acronym

HACER

Enrollment

Registered

2010-06-22

Start date

2010-06-30

Completion date

2010-12-31

Last updated

2015-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitis, Hip arthritis, Infliximab

Brief summary

This trial is designed to measure improvement of hip involvement in patients with ankylosing spondylitis (AS) after receiving 4 doses of infliximab. Participants will receive infliximab 5 mg/kg (as an intravenous perfusion over a period of 2 hours) at Weeks 0, 2, 6, and 14, consistent with the approved dosing regimen described in the label. Participants will be evaluated for hip pain, functional capacity and stiffness before and after 14 weeks (4 doses) of treatment. Further treatment after 4 doses is based on standard clinical practice as determined by the trial site.

Interventions

DRUGInfliximab

Infliximab 5 mg/kg administered as an intravenous perfusion over a period of 2 hours at Weeks 0, 2, 6, and 14, as indicated in the Summary of Product Characteristics

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years of age or older * Ankylosing spondylitis (AS) diagnosis * Have all 3 of the following: * Presence of hip pain (nocturnal inflammatory pain) * Limitation of hip mobility * Patient's Global Assessment Visual Analog Scale (0-10 cm) ≥4 cm. * Inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) * Eligible to be treated with Infliximab (Remicade®)

Exclusion criteria

* Causes of coaxalgia other than coxitis of AS, demonstrated by images or laboratory tests * Women who are pregnant or nursing or plan to nurse or become pregnant * Serious infections like sepsis, abscesses. * History of or current certain infections * History of or current certain medical conditions

Design outcomes

Primary

Measure	Time frame
Number of participants with clinical improvement assessed by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire	Baseline and Week 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026