A Study Treating Participants With Early Axial Spondyloarthritis (axSpA) Taking an Intense Treatment Approach Versus Routine Treatment

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-12

Study Completion Date

2017-12-21

Brief Summary

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A study comparing a treat-to-target (T2T) intense treatment approach with routine treatment (Standard of Care \[SOC\]) in reducing disease activity in participants with axial spondyloarthritis (axSpA).

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Detailed Description

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Conditions

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Axial Spondyloarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treat-to-Target (T2T)

Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2 or treatment with the chosen NSAID was not tolerated, , participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.

Group Type EXPERIMENTAL

Adalimumab

Intervention Type BIOLOGICAL

Administered every other week by subcutaneous injection for up to 48 weeks, depending on participants' disease activity.

Standard of Care (SOC)

Participants received treatment as prescribed by their physician according to the local standard of care.

Group Type ACTIVE_COMPARATOR

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Intervention Type OTHER

ASAS recommended NSAID doses to treat axial spondyloarthritis.

Interventions

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Adalimumab

Administered every other week by subcutaneous injection for up to 48 weeks, depending on participants' disease activity.

Intervention Type BIOLOGICAL

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

ASAS recommended NSAID doses to treat axial spondyloarthritis.

Intervention Type OTHER

Other Intervention Names

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Humira ABT-D2E7 Routine practice

Eligibility Criteria

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Inclusion Criteria

* Signed written informed consent before start of study-related assessments or procedures
* Diagnosis of axSpA (either ankylosing spondylitis or non-radiographic axSpA) and fulfilling the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axSpA
* Participants aged ≥ 18 years
* Disease duration \< 5 years
* Participants must have a Baseline disease activity as defined by an ASDAS ≥ 2.1 or a Bath AS Disease Activity Index (BASDAI) ≥ 4
* NSAID-naive or not treated with the maximal recommended NSAID dose during the last 2 weeks prior to the Baseline visit
* Participants must never have failed a NSAID taken at maximal recommended dose for 2 weeks or more.

Exclusion Criteria

* Contraindications for NSAIDs or tumor necrosis factor (TNF) blocker according to local labeling
* If entering the study on concomitant NSAIDs, participants taking the maximal recommended dose during the last 2 weeks prior to the Baseline Visit or have failed or developed intolerance to a NSAID taken at maximal recommended dose for 2 weeks or more at any time
* Prior exposure to any anti-TNF therapy; any biologic therapy with a potential therapeutic impact on SpA, or participant has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Baseline visit.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No