Trial Outcomes & Findings for Novel MRI ANd Biomarkers in GOlimumab-treated Patients With Axial Spondyloarthritis (NCT NCT02011386)

NCT ID: NCT02011386

Last Updated: 2020-08-17

Results Overview

At least 50% reduction in BASDAI score at follow-up compared with BASDAI score at baseline

• Recruitment status: COMPLETED
• Target enrollment: 53 participants
• Primary outcome timeframe: Week 52
• Results posted on: 2020-08-17

Participant Flow

Participant milestones

Measure	Treatment Treatment: Injection Golimumab 50 mg every month on the same date
Overall Study STARTED	53
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Treatment Treatment: Injection Golimumab 50 mg every month on the same date
Overall Study Non-compliance	2
Overall Study Lack of Efficacy	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Treatment n=53 Participants Treatment: Injection Golimumab 50 mg every month on the same date
Age, Continuous	35 years n=53 Participants
Sex: Female, Male Female	25 Participants n=53 Participants
Sex: Female, Male Male	28 Participants n=53 Participants
Region of Enrollment Denmark	53 participants n=53 Participants
Fulfilment of the radiographic part of the modified New York criteria	33 Participants n=53 Participants
Body mass index	24 kg/m2 n=53 Participants
Symptom duration	5.1 years n=53 Participants
Positive for HLA-B27	40 Participants n=53 Participants
hsCRP	6.8 mg/L n=53 Participants
Ankylosing Spondylitis Disease Activity Score (ASDAS)	3.6 units on a scale n=53 Participants
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	6.2 units on a scale n=53 Participants
Bath Ankylosing Spondylitis Functional Index (BASFI)	4.6 units on a scale n=53 Participants
Bath Ankylosing Spondylitis Metrology Index (BASMI)	2 units on a scale n=53 Participants
Chest expansion	4.0 cm n=53 Participants
Swollen joint count of 66 joints	0 joints n=53 Participants
Tender joint count of 68 joints	0 joints n=53 Participants
Tender enthesis count	3 entheses n=53 Participants
Pain score	6.9 units on a scale n=53 Participants
Patient's global score	7.5 units on a scale n=53 Participants
Physician's global score	4.9 units on a scale n=53 Participants
Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)	0 units on a scale n=53 Participants
Canada-Denmark (CANDEN) Magnetic Resonance Imaging (MRI) Spine Inflammation Index	8 units on a scale n=53 Participants
Canada-Denmark (CANDEN) Magnetic Resonance Imaging (MRI) Spine Fat Metaplasia Score	3 units on a scale n=53 Participants
Canada-Denmark (CANDEN) Magnetic Resonance Imaging (MRI) Spine Erosion Score	0 units on a scale n=53 Participants
Canada-Denmark (CANDEN) Magnetic Resonance Imaging (MRI) Spine New Bone Formation Score	0 units on a scale n=53 Participants
SPARCC MRI Spine Inflammation Index	8 units on a scale n=53 Participants
SPARCC MRI Sacroiliac Joint Inflammation Index	13 units on a scale n=53 Participants
SPARCC MRI Sacroiliac Joint Structural Score - Fat	2 units on a scale n=53 Participants
SPARCC MRI Sacroiliac Joint Structural Score - Erosion	6 units on a scale n=53 Participants
SPARCC MRI Sacroiliac Joint Structural Score - Backfill	0 units on a scale n=53 Participants
SPARCC MRI Sacroiliac Joint Structural Score - Ankylosis	0 units on a scale n=53 Participants
MRI Peripheral Joints and Entheses Inflammation Index	7 units on a scale n=53 Participants
Assessment of Spondyloarthritis International Society (ASAS) criteria: Inflammatory back pain	50 Participants n=53 Participants
Assessment of Spondyloarthritis International Society (ASAS) criteria: Arthritis	12 Participants n=53 Participants
Assessment of Spondyloarthritis International Society (ASAS) criteria: Heel enthesitis	12 Participants n=53 Participants
Assessment of Spondyloarthritis International Society (ASAS) criteria: Uveitis	9 Participants n=53 Participants
Assessment of Spondyloarthritis International Society (ASAS) criteria: Dactylitis	3 Participants n=53 Participants
Assessment of Spondyloarthritis International Society (ASAS) criteria: Psoriasis	6 Participants n=53 Participants
Assessment of Spondyloarthritis International Society (ASAS) criteria: Inflammatory bowel disease	2 Participants n=53 Participants
Assessment of Spondyloarthritis International Society (ASAS) criteria: Good response to NSAIDs	38 Participants n=53 Participants
Assessment of Spondyloarthritis International Society criteria: Family history of spondyloarthritis	15 Participants n=53 Participants
Assessment of Spondyloarthritis International Society (ASAS) criteria: Elevated C-reactive protein	34 Participants n=53 Participants
csDMARDs at baseline Sulfasalazine at baseline	2 Participants n=53 Participants
csDMARDs at baseline Methotrexate at baseline	1 Participants n=53 Participants
csDMARDs at baseline Leflunomide at baseline	1 Participants n=53 Participants
csDMARDs at baseline No csDMARDs	49 Participants n=53 Participants

PRIMARY outcome

Timeframe: Week 52

At least 50% reduction in BASDAI score at follow-up compared with BASDAI score at baseline

Outcome measures

Measure	Treatment n=53 Participants Treatment: Injection Golimumab 50 mg every month on the same date
Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50)	31 Participants

SECONDARY outcome

Timeframe: Week 16

At least 50% decrease or at least an improvement of 2.0 in BASDAI, when measured on a scale with range 0-10.

Outcome measures

Measure	Treatment n=53 Participants Treatment: Injection Golimumab 50 mg every month on the same date
BASDAI 50% or 2.0 Improvement	36 Participants

SECONDARY outcome

Timeframe: Week 52

At least 50% decrease or at least an improvement of 2.0 in BASDAI, when measured on a scale with range 0-10.

Outcome measures

Measure	Treatment n=53 Participants Treatment: Injection Golimumab 50 mg every month on the same date
BASDAI 50% or 2.0 Improvement	36 Participants

SECONDARY outcome

Timeframe: Week 16

Decrease in ASDAS score at follow-up compared with ASDAS score at baseline of at least 1.1.

Outcome measures

Measure	Treatment n=53 Participants Treatment: Injection Golimumab 50 mg every month on the same date
Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)	40 Participants

SECONDARY outcome

Timeframe: Week 52

Decrease in ASDAS score at follow-up compared with ASDAS score at baseline of at least 1.1.

Outcome measures

Measure	Treatment n=53 Participants Treatment: Injection Golimumab 50 mg every month on the same date
Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)	34 Participants

SECONDARY outcome

Timeframe: Week 16

Maximum 1 disco-vertebral unit with inflammation present.

Outcome measures

Measure	Treatment n=53 Participants Treatment: Injection Golimumab 50 mg every month on the same date
MRI Spine Remission	32 Participants

SECONDARY outcome

Timeframe: Week 16

At least 50% reduction in Canada-Denmark (CANDEN) MRI spine inflammation score.

Outcome measures

Measure	Treatment n=53 Participants Treatment: Injection Golimumab 50 mg every month on the same date
MRI-SPINE-50	30 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 16

At least 50% decrease in Spondyloarthritis Research Consortium of Canada (SPARCC) MRI sacroiliac joint inflammation index

Outcome measures

Measure	Treatment n=53 Participants Treatment: Injection Golimumab 50 mg every month on the same date
MRI-SIJ-50	29 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 16

At least 50% reduction in MRI Peripheral Joints and Entheses Inflammation Index. MRIs of 74 peripheral joints were evaluated separately for synovitis and osteitis (i.e. bone marrow edema) and 30 peripheral entheses were evaluated separately for soft tissue inflammation and osteitis. All types of lesions (i.e. joint synovitis, joint osteitis, entheseal soft tissue inflammation and entheseal osteitis) were scored on a semi-quantitative scale of 0-2 ('none', 'mild', 'moderate to severe').

Outcome measures

Measure	Treatment n=53 Participants Treatment: Injection Golimumab 50 mg every month on the same date
MRI-PERIPH-50	17 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 16

Inflammation in 2 or fewer quadrants as assessed slice by slice across MRI slices that depict the cartilagenous compartment of the sacroiliac joints.

Outcome measures

Measure	Treatment n=53 Participants Treatment: Injection Golimumab 50 mg every month on the same date
MRI SI Joint Remission	24 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 16

A score of maximally 2 of the MRI Peripheral Joints and Entheses Inflammation Index.

Outcome measures

Measure	Treatment n=53 Participants Treatment: Injection Golimumab 50 mg every month on the same date
MRI Peripheral Joints and Entheses Inflammation Remission	16 Participants

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment n=53 participants at risk Treatment: Injection Golimumab 50 mg every month on the same date
Infections and infestations Influenza	7.5% 4/53 • Number of events 4 • Adverse events were collected from the date of start of golimumab treatment and until the date of the week 52 visit or the date of early termination.
Infections and infestations Nasopharyngitis	13.2% 7/53 • Number of events 9 • Adverse events were collected from the date of start of golimumab treatment and until the date of the week 52 visit or the date of early termination.
General disorders Fatigue	5.7% 3/53 • Number of events 3 • Adverse events were collected from the date of start of golimumab treatment and until the date of the week 52 visit or the date of early termination.
Infections and infestations Pharyngitis	5.7% 3/53 • Number of events 3 • Adverse events were collected from the date of start of golimumab treatment and until the date of the week 52 visit or the date of early termination.
Infections and infestations Tooth infection	5.7% 3/53 • Number of events 3 • Adverse events were collected from the date of start of golimumab treatment and until the date of the week 52 visit or the date of early termination.
Infections and infestations Pneumonia	5.7% 3/53 • Number of events 3 • Adverse events were collected from the date of start of golimumab treatment and until the date of the week 52 visit or the date of early termination.
Nervous system disorders Dizziness	5.7% 3/53 • Number of events 3 • Adverse events were collected from the date of start of golimumab treatment and until the date of the week 52 visit or the date of early termination.
Skin and subcutaneous tissue disorders Rash	5.7% 3/53 • Number of events 3 • Adverse events were collected from the date of start of golimumab treatment and until the date of the week 52 visit or the date of early termination.

Additional Information

Professor Mikkel Østergaard, MD, PhD, DMSc

Rigshospitalet, Denmark

Phone: +45 38633014

Email: mo@dadlnet.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place