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

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ClinicalTrials.gov Identifier: NCT02897115
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : January 9, 2018
Sponsor:
Collaborators:
Improvement by Movement GmbH, Germany
Hannover Medical School
IST GmbH, Germany
Information provided by (Responsible Party):
AbbVie

Brief Summary:
A study comparing a treat-to-target (T2T) intense treatment approach in participants with axial spondyloarthritis (axSpA) with routine treatment (Standard of Care (SOC)) concerning a reduction in disease activity.

Condition or disease Intervention/treatment Phase
Axial Spondyloarthritis Biological: Adalimumab Other: Standard of Care (SOC) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STRIKE - Treating Patients With Early Axial Spondyloarthritis to Target - a 1 Year Randomized Controlled Study Taking an Intense Treatment Approach Versus Routine Treatment
Actual Study Start Date : September 12, 2016
Actual Primary Completion Date : December 21, 2017
Actual Study Completion Date : December 21, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: Target to Treat (T2T)
Depending on their disease activity, participants' basic NSAID therapy (at full recommended dose) will be changed after 4 weeks to another NSAID at its full recommended dose. After another 4 weeks, if applicable based on their disease activity, participants will receive Adalimumab in combination with their NSAID therapy.
Biological: Adalimumab
Administered subcutaneously for a maximum of 48 weeks, depending on participants' disease activity observed.
Other Names:
  • Humira
  • ABT-D2E7

Standard of Care (SOC)
Participants will receive treatment as prescribed by their physicians.
Other: Standard of Care (SOC)
Treatment according to participants' physicians' routine practice (local SOC).
Other Name: Routine practice




Primary Outcome Measures :
  1. Percentage of participants with Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease [ Time Frame: At Week 32 ]
    ASDAS inactive disease is defined as ASDAS < 1.3.


Secondary Outcome Measures :
  1. Percentage of participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease state [ Time Frame: Up to Week 52 ]
    This accounts for participants with ASDAS <1.3.

  2. Percentage of subjects achieving ASDAS major improvement [ Time Frame: Up to Week 52 ]
    The 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 (CRP or ESR) as an objective measure of inflammation.

  3. Change in Swollen Joint Count (66 joints) [ Time Frame: From Week 0 (baseline) to Week 52 ]
    An assessment of 66 joints will be done by physical examination at the designated study visits. Joint swelling will be classified as present (1), absent (0), replaced (9), or no assessment (NA).

  4. Bath AS Disease Activity Index [ Time Frame: Up to Week 52 ]
    This is used to measure disease activity.

  5. Percentage of participants achieving ASAS 40 [ Time Frame: Up to Week 52 ]
    It is defined as improvement of >= 40% in ASAS index.

  6. Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA) [ Time Frame: Up to Week 52 ]
    This is used to assess the effect of participant's axial spondyloarthritis on their ability to work and perform regular activities.

  7. Erythrocyte sedimentation rate [ Time Frame: Up to Week 52 ]
    ESR will be evaluated at the site and expressed in mm/hg (1st hour).

  8. Percentage of participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) high disease activity [ Time Frame: Up to Week 52 ]
    This accounts for participants with ASDAS >= 2.1 to < 3.5.

  9. Bath Ankylosing Spondylitis Functional Index (BASFI) Numerical Rating Scale (NRS) score [ Time Frame: Up to Week 52 ]
    This is used to assess function. The score ranges from 0 (easy to perform an activity) to 10 (impossible to perform an activity).

  10. European Quality of Life-5 Dimensions (EQ-5D) Questionnaire [ Time Frame: Up to Week 52 ]
    The EQ-5D is an international, standardized, generic instrument for describing and valuing health status.

  11. Change in Physician's Global Assessment of Disease Activity [ Time Frame: From Week 0 (baseline) to Week 52 ]
    NRS will be used to assess Physician's Global Assessment of Disease Activity. The left end of the NRS (0) signifies the absence of symptoms and the right end (10) signifies maximum activity.

  12. Percentage of subjects achieving ASDAS clinically important improvement [ Time Frame: Up to Week 52 ]
    The 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 (CRP or ESR) as an objective measure of inflammation.

  13. Change in the Dactylitis count (0 - 20) [ Time Frame: From Week 0 (baseline) to Week 52 ]
    Evaluation for dactylitis will be conducted at the designated study visits to assess the presence or absence of dactylitis in all 20 of the subjects' digits.

  14. Change in Tender Joint Count (68 joints) [ Time Frame: From Week 0 (baseline) to Week 52 ]
    An assessment of 68 joints will be done by physical examination at the designated study visits. Joint pain/tenderness will be classified as present (1), absent (0), replaced (9), or no assessment (NA)

  15. Change from Baseline in ASDAS [ Time Frame: From Week 0 (baseline) to Week 52 ]
    The 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 (CRP or ESR) as an objective measure of inflammation.

  16. Percentage of participants achieving BASDAI 50 response [ Time Frame: Up to Week 52 ]
    This accounts for participants achieving 50% improvement in BASDAI.

  17. Percentage of participants achieving ASAS 20 [ Time Frame: Up to Week 52 ]
    It is defined as improvement of >= 20% in ASAS index.

  18. Percentage of participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) very high disease activity [ Time Frame: Up to Week 52 ]
    This accounts for participants with ASDAS >= 3.5.

  19. Percentage of participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) moderate disease activity [ Time Frame: Up to Week 52 ]
    This accounts for participants with ASDAS >= 1.3 to < 2.1

  20. Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI) [ Time Frame: Up to Week 52 ]
    This is used to asses overall functioning.

  21. Anterior Uveitis [ Time Frame: Up to Week 52 ]
    This is assessed by the physician.

  22. Change in Patient's Global Assessment of Disease Activity [ Time Frame: From Week 0 (baseline) to Week 52 ]
    NRS will be used to assess Patient's Global Assessment of Disease Activity. The left end of the NRS (0) signifies the absence of symptoms and the right end (10) signifies maximum activity.

  23. Change in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) [ Time Frame: From Week 0 (baseline) to Week 52 ]
    The MASES evaluation will be conducted at the designated study visits to assess the presence or absence of enthesitis at 13 different sites, noting the subjects' responses.

  24. Change in Patient's Global Assessment of Pain [ Time Frame: From Week 0 (baseline) to Week 52 ]
    NRS will be used to assess Patient's Global Assessment of Pain. The left end of the NRS (0) signifies the absence of symptoms and the right end (10) signifies maximum activity.

  25. C-reactive Protein [ Time Frame: Up to Week 52 ]
    Testing for CRP will be performed on specimens collected at the designated study visits.

  26. ASAS partial remission [ Time Frame: Up to Week 52 ]
    It indicates absolute score of < 2 units for each of the domains listed in the criteria.

  27. Percentage of participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) low disease activity [ Time Frame: Up to Week 52 ]
    This accounts for participants with ASDAS <2.1.

  28. Berlin magnetic resonance imaging score [ Time Frame: Up to Week 52 ]
    This is used to assess active inflammation.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897115


Locations
Germany
Rheumatologische Gemeinschafts
Bad Neuenahr, Germany, 53474
Rheumatologische Schwerpunktpr
Berlin, Germany, 12161
Praxis fuer Rheumatologie
Berlin, Germany, 12163
Charite-Univ Berlin
Berlin, Germany, 12203
Schwerpunktpraxis fuer Rheumat
Burghausen, Germany, 84489
CIRI GmbH
Frankfurt, Germany, 60528
Medizinische Universitaetsklin
Freiburg, Germany, 79106
Hamburger Rheuma I
Hamburg, Germany, 22391
Rheumazentrum Ruhrgebiet
Herne, Germany, 44649
Univ Kliniken des Saarlandes
Homburg, Germany, 66424
SMO MD GmbH
Magdeburg, Germany, 39120
Rheumapraxis An der Hase
Osnabrück, Germany, 49074
MVZ Planegg
Planegg, Germany, 82152
Knappschaftsklinikum Saar GmbH
Puettlingen, Germany, 66346
Rheumaforschung Studienambulan
Ratingen, Germany, 40882
Rheumatologische Praxis
Rendsburg, Germany, 24768
Krankenhaus St. Josef
Wuppertal, Germany, 42105
Sponsors and Collaborators
AbbVie
Improvement by Movement GmbH, Germany
Hannover Medical School
IST GmbH, Germany
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02897115     History of Changes
Other Study ID Numbers: W15-679
2015-005398-18 ( EudraCT Number )
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Axial Spondyloarthritis
Humira

Additional relevant MeSH terms:
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents