SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis

Browse trials for

• Spondylitis 623
• Spondylarthritis 597
• Axial Spondyloarthritis 203

Keywords

• axial spondyloarthritis
• ankylosing spondylitis
• non-radiographic axial spondyloarthritis
• inflammatory back pain
• spinal pain
• secukinumab
• AIN457

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 383 is above the median of 92 across 349 interventional studies indexed under Spondylitis.

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Secukinumab 150 mg (Group A)

  Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4

  Biological: AIN457

• Placebo comparator
  Placebo (Group B)

  Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4

  Biological: AIN457 · Drug: AIN457 Placebo

• Active comparator
  Arm A1

  Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20

  Biological: AIN457 · Drug: AIN457 Placebo

• Active comparator
  Arm A2

  Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20

  Biological: AIN457 · Drug: AIN457 Placebo

• Active comparator
  Arm A3

  Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20

  Biological: AIN457

• Active comparator
  Arm B1

  Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20

  Biological: AIN457 · Drug: AIN457 Placebo

• Active comparator
  Arm B2

  Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20

  Biological: AIN457

Interventions

• BiologicalAIN457

  anti IL-17a monoclonal antibody

  Also known as: secukinumab

• DrugAIN457 Placebo

  Placebo matching AIN457

  Also known as: Placebo

Primary outcomes

1. Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1)

   The spinal pain numerical rating scale (NRS) is an 11-point scale to assess pain intensity in patients who are able to self-report. It is an 11-point scale from 0-10: 1) "0" = no pain. 2) "10" = the most intense pain imaginable. To calculate the average spinal pain, the patient was asked to answer 2 questions to get 2 pain ratings, the total spinal pain corresponding to the intensity of spinal pain experienced on an average over 24 hours during the previous week and the nocturnal back pain corresponding to the intensity of spinal pain experienced on an average over the night during the previous week.

   Time frame: Week 8

Secondary outcomes

1. Percentage of Participants With a Bath Ankylosing Spondylitis Disease Activity Index Score Below 4 at Week 8 (Treatment Period 1)

   The Bath ankylosing spondylitis disease activity index (BASDAI) consists of a 0 through 10 scale, which is used to answer 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis. To give each symptom equal weighting, the mean (average) of the 2 scores relating to morning stiffness (questions 5 and 6) is taken. The mean of questions 5 and 6 is added to the scores from questions 1-4. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score.

   Time frame: Week 8

Baseline characteristics

Publications

• Poddubnyy D, Pournara E, Zielinska A, Baranauskaite A, Jimenez AM, Sadhu S, Schulz B, Rissler M, Perella C, Marzo-Ortega H. Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial. Ther Adv Musculoskelet Dis. 2021 Oct 22;13:1759720X211051471. doi: 10.1177/1759720X211051471. eCollection 2021. PubMed 34707696 ↗

Related links

• A Plain Language Trial Summary is available on novartisclinicatrials.com ↗

Study documents

• Study protocol · Feb 7, 2017
• Statistical analysis plan · May 29, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Novartis is commited to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.