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

NCT02897115 | Terminated Phase 4 Results

• 2 other identifiers: W15-6792015-005398-18
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Axial Spondyloarthritis

Keywords

Axial Spondyloarthritis; Humira

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an Ankylosing Spondylitis Disease Activity Score (ASDAS) of Inactive Disease at Week 32

  ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (C-reactive protein \[CRP\] or erythrocyte sedimentation rate \[ESR\]) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: \< 1.3 for "inactive disease"; ≥ 1.3 to \< 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and \> 3.5 for "very high disease activity." The percentage of participants with ASDAS inactive disease (defined as ASDAS \< 1.3) calculated using CRP is reported.

  Week 32

Secondary Outcomes (32)

• Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

  Baseline, week 32, and week 52

• Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Presenteeism

  Baseline, week 32, and week 52

• Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Absenteeism

  Baseline, week 32, and week 52

• Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Total Work Productivity Impairment

  Baseline, week 32, and week 52

• Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Total Activity Impairment

  Baseline, week 32, and week 52

Study Arms (2)

Treat-to-Target (T2T)

EXPERIMENTAL

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.

Biological: Adalimumab

Standard of Care (SOC)

ACTIVE COMPARATOR

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

Other: Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Interventions

Adalimumab BIOLOGICAL

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

Also known as: Humira, ABT-D2E7

Treat-to-Target (T2T)

Non-steroidal Anti-inflammatory Drugs (NSAIDs) OTHER

ASAS recommended NSAID doses to treat axial spondyloarthritis.

Also known as: Routine practice

Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead
• IST GmbH, Germany: collaborator
• Hannover Medical School: collaborator
• Improvement by Movement GmbH, Germany: collaborator

Related Links

• Related Info

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

Adalimumab; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 13, 2016
• Study Start: September 12, 2016
• Primary Completion: December 21, 2017
• Study Completion: December 21, 2017
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2018-11