Trial Outcomes & Findings for Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab (NCT NCT03557853)

NCT ID: NCT03557853

Last Updated: 2024-08-15

Results Overview

The BASFI is a self-assessment instrument for defining functional ability in patients with AS. Contains 10 items: 8 items concerning activities referring to the functional anatomy of the patients (bending, reaching, changing position, standing, turning, and climbing steps) and 2 items assessing the patients' ability to cope with everyday life. Consists of Numeric response scale (0-10) from "easy" to "impossible." The mean of the 10 individual scales (scores) gives the BASFI score - a value between 0 and 10 with 0 reflecting no functional impairments and 10 reflecting maximal impairment.

• Recruitment status: COMPLETED
• Target enrollment: 39 participants
• Primary outcome timeframe: From baseline to 12 months
• Results posted on: 2024-08-15

Participant Flow

At least 18 patients to be recruited and followed-up for 12 months for preliminary statistical analysis based on the primary end-point (change of BASFI in 12 months after baseline).

Participant milestones

Measure	Golimumab Injection Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
12 Months of Follow-up: Interim Analysis STARTED	39
12 Months of Follow-up: Interim Analysis COMPLETED	22
12 Months of Follow-up: Interim Analysis NOT COMPLETED	17
24 Weeks of Follow-up: Final Analysis STARTED	39
24 Weeks of Follow-up: Final Analysis COMPLETED	30
24 Weeks of Follow-up: Final Analysis NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Golimumab Injection n=39 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
Age, Continuous	35.21 years STANDARD_DEVIATION 11.0 • n=39 Participants
Sex: Female, Male Female	13 Participants n=39 Participants
Sex: Female, Male Male	26 Participants n=39 Participants
Region of Enrollment Russia	39 Participants n=39 Participants
Coxitis symptoms duration	24 months n=39 Participants
Bath Ankylosing Spondylitis Functionality Index (BASFI)	3.9 units on a scale n=30 Participants • Results of clinical effect assessment population are presented (n=30)
Bath Ankylosing Spondylitis Metrological Index (BASMI)	3.0 units on a scale n=30 Participants • Results of clinical effect assessment population are presented (n=30)
Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)	3.5 units on a scale n=30 Participants • Results of clinical effect assessment population are presented (n=30)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	4.6 units on a scale n=30 Participants • Results of clinical effect assessment population are presented (n=30)
Bath Ankylosing Spondylitis Radiographic Score (BASRI) Right Hip	1.0 units on a scale n=30 Participants • Results of clinical effect assessment population are presented (n=30)
Bath Ankylosing Spondylitis Radiographic Score (BASRI) Left Hip	1.0 units on a scale n=30 Participants • Results of clinical effect assessment population are presented (n=30)
Percentage of participants without MRI Inflammatory Lesions Right Hip	4 Participants n=19 Participants • Data are based on available MRI results suitable for paired analysis.
Percentage of participants without MRI Inflammatory Lesions Left Hip	3 Participants n=19 Participants • Data are based on available MRI results suitable for paired analysis.
Percentage of patients without Hips US Inflammatory Lesions Right Hip	3 Participants n=21 Participants • Data are based on available US results suitable for paired analysis.
Percentage of patients without Hips US Inflammatory Lesions Left Hip	3 Participants n=21 Participants • Data are based on available US results suitable for paired analysis.

PRIMARY outcome

Timeframe: From baseline to 12 months

Population: Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30)

The BASFI is a self-assessment instrument for defining functional ability in patients with AS. Contains 10 items: 8 items concerning activities referring to the functional anatomy of the patients (bending, reaching, changing position, standing, turning, and climbing steps) and 2 items assessing the patients' ability to cope with everyday life. Consists of Numeric response scale (0-10) from "easy" to "impossible." The mean of the 10 individual scales (scores) gives the BASFI score - a value between 0 and 10 with 0 reflecting no functional impairments and 10 reflecting maximal impairment.

Outcome measures

Measure	Golimumab Injection n=30 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
BASFI (Bath Ankylosing Spodylitis Functionality Index) at 12 Months of Follow-up	1.0 units on a scale Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: From baseline to 24 months

Population: Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30)

The BASFI is a self-assessment instrument for defining functional ability in patients with AS. Contains 10 items: 8 items concerning activities referring to the functional anatomy of the patients (bending, reaching, changing position, standing, turning, and climbing steps) and 2 items assessing the patients' ability to cope with everyday life. Consists of Numeric response scale (0-10) from "easy" to "impossible." The mean of the 10 individual scales (scores) gives the BASFI score - a value between 0 and 10 with 0 reflecting no functional impairments and 10 reflecting maximal impairment.

Outcome measures

Measure	Golimumab Injection n=30 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
BASFI (Bath Ankylosing Spodylitis Functionality Index) at 24 Months of Follow-up	1.1 units on a scale Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30)

The Bath Ankylosing Spondylitis Metrology Index (BASMI) is used to assess mobility of spine and hip joints. The BASMI score is a sum of the 5 measures: cervical rotation (>85.0° to ≤8.5°), tragus to wall distance (<10 cm to ≥38 cm), lumbar flexion (>7.0 cm to ≤0.7 cm), lumbar side flexion (>20.0 cm to <1.2 cm), and intermalleolar distance (≥120 cm to <30 cm). Each item is scored from 0 to 10 based on defined cut points. The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation.

Outcome measures

Measure	Golimumab Injection n=30 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
BASMI (Bath Ankylosing Spodylitis Mobility Index) at 12 Months of Follow-up	1.0 units on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: From baseline to 24 months

Population: Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30)

The Bath Ankylosing Spondylitis Metrology Index (BASMI) is used to assess mobility of spine and hip joints. The BASMI score is a sum of the 5 measures: cervical rotation (>85.0° to ≤8.5°), tragus to wall distance (<10 cm to ≥38 cm), lumbar flexion (>7.0 cm to ≤0.7 cm), lumbar side flexion (>20.0 cm to <1.2 cm), and intermalleolar distance (≥120 cm to <30 cm). Each item is scored from 0 to 10 based on defined cut points. The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation.

Outcome measures

Measure	Golimumab Injection n=30 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
BASMI (Bath Ankylosing Spodylitis Mobility Index) at 24 Months of Follow-up	0.5 units on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30)

The ASDAS-CRP is to measure disease activity based on a composite score. The score includes patient-reported assessments of back pain, duration of morning stiffness, peripheral joint pain and/or swelling, general well-being, and a serologic marker of inflammation C-reactive protein (CRP). Patient response items and a serologic measure of inflammation are mathematically combined to give the ASDAS-CRP. Score ranges from zero (reflecting no disease activity) with the upper end of the scale being determined by the level of the CRP.

Outcome measures

Measure	Golimumab Injection n=30 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 12 Months of Follow-up	1.3 units on a scale Interval 1.0 to 1.9

SECONDARY outcome

Timeframe: From baseline to 24 months

Population: Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30)

The ASDAS-CRP is to measure disease activity based on a composite score. The score includes patient-reported assessments of back pain, duration of morning stiffness, peripheral joint pain and/or swelling, general well-being, and a serologic marker of inflammation C-reactive protein (CRP). Patient response items and a serologic measure of inflammation are mathematically combined to give the ASDAS-CRP. Score ranges from zero (reflecting no disease activity) with the upper end of the scale being determined by the level of the CRP.

Outcome measures

Measure	Golimumab Injection n=30 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 24 Months of Follow-up	1.1 units on a scale Interval 0.9 to 1.7

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30)

The BASDAI is an instrument to measure disease activity in AS based on a composite score.The index includes patient-reported levels of back pain, fatigue, peripheral joint pain and swelling, localized tenderness, and the duration and severity of morning stiffness. It contains 6 items with numeric response scales (0-10) or visual analog scales (VAS, 0-10 cm) anchored by adjectival descriptors "none" and "very severe." Duration of morning stiffness is anchored by a time scale (0-2 or more hours).

Outcome measures

Measure	Golimumab Injection n=30 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
BASDAI (Bath AS Disease Activity Index) at 12 Months of Follow-up	1.0 units on a scale Interval 0.6 to 2.9

SECONDARY outcome

Timeframe: From baseline to 24 months

Population: Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30)

The BASDAI is an instrument to measure disease activity in AS based on a composite score.The index includes patient-reported levels of back pain, fatigue, peripheral joint pain and swelling, localized tenderness, and the duration and severity of morning stiffness. It contains 6 items with numeric response scales (0-10) or visual analog scales (VAS, 0-10 cm) anchored by adjectival descriptors "none" and "very severe." Duration of morning stiffness is anchored by a time scale (0-2 or more hours).

Outcome measures

Measure	Golimumab Injection n=30 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
BASDAI (Bath AS Disease Activity Index) at 24 Months of Follow-up	1.1 units on a scale Interval 0.2 to 3.0

SECONDARY outcome

Timeframe: From baseline to 12 months

Population: Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30)

The BASRI-hip is a score of structural impairment of hip on X-ray images:

0 - no change; 1 - suspicious: focal joint space narrowing; 2 - mild: circumferential joint space narrowing >2mm; 3 - moderate: circumferential joint space narrowing ≤ 2mm or bone-on-bone apposition of <2 cm; 4 - severe: bone deformity or bone-on-bone apposition of ≥2 cm.

Outcome measures

Measure	Golimumab Injection n=30 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 12 Months of Follow-up Right Hip	1.0 units on a scale Interval 1.0 to 2.0
BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 12 Months of Follow-up Left Hip	1.0 units on a scale Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: From baseline to 24 months

Population: Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30)

The BASRI-hip is a score of structural impairment of hip on X-ray images:

0 - no change; 1 - suspicious: focal joint space narrowing; 2 - mild: circumferential joint space narrowing >2mm; 3 - moderate: circumferential joint space narrowing ≤ 2mm or bone-on-bone apposition of <2 cm; 4 - severe: bone deformity or bone-on-bone apposition of ≥2 cm.

Outcome measures

Measure	Golimumab Injection n=30 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 24 Months of Follow-up Right Hip	1.0 units on a scale Interval 1.0 to 2.0
BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 24 Months of Follow-up Left Hip	2.0 units on a scale Interval 1.0 to 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months from the baseline

Percentage of participants without MRI Inflammatory Lesions in the Right Hip at 6 months of follow-up based on result available and suitable for paired analysis.

There were no formal scores for MRI of hips at time of study initiation. Information on hips MRI (STIR (short tau inversion recovery) sequence and fat-saturated contrast-enhanced T1-weighted sequence) were collected based on availability: No lesions suggesting inflammation; Subchondral bone marrow edema (expressed as Yes or No); Joint effusion (expressed as Yes or No); Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No); Fatty degeneration (expressed as Yes or No).

Outcome measures

Measure	Golimumab Injection n=19 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
Percentage of Participants Without MRI Inflammatory Lesions in the Right Hip at 6 Months of Follow-up	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months from the baseline

Percentage of participants without MRI Inflammatory Lesions in the Left Hip at 6 months of follow-up based on result available and suitable for paired analysis.

There were no formal scores for MRI of hips at time of study initiation. Information on hips MRI (STIR (short tau inversion recovery) sequence and fat-saturated contrast-enhanced T1-weighted sequence) were collected based on availability: No lesions suggesting inflammation; Subchondral bone marrow edema (expressed as Yes or No); Joint effusion (expressed as Yes or No); Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No); Fatty degeneration (expressed as Yes or No).

Outcome measures

Measure	Golimumab Injection n=19 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
Percentage of Participants Without MRI Inflammatory Lesions in the Left Hip at 6 Months of Follow-up	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months from the baseline

Percentage of participants without MRI Inflammatory Lesions in the Right Hip at 12 months of follow-up based on result available and suitable for paired analysis.

There were no formal scores for MRI of hips at time of study initiation. Information on hips MRI (STIR (short tau inversion recovery) sequence and fat-saturated contrast-enhanced T1-weighted sequence) were collected based on availability: No lesions suggesting inflammation; Subchondral bone marrow edema (expressed as Yes or No); Joint effusion (expressed as Yes or No); Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No); Fatty degeneration (expressed as Yes or No).

Outcome measures

Measure	Golimumab Injection n=13 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
Percentage of Participants Without MRI Inflammatory Lesions in the Right Hip at 12 Months of Follow-up	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months from the baseline

Percentage of participants without MRI Inflammatory Lesions in the Left Hip at 12 months of follow-up based on result available and suitable for paired analysis.

There were no formal scores for MRI of hips at time of study initiation. Information on hips MRI (STIR (short tau inversion recovery) sequence and fat-saturated contrast-enhanced T1-weighted sequence) were collected based on availability: No lesions suggesting inflammation; Subchondral bone marrow edema (expressed as Yes or No); Joint effusion (expressed as Yes or No); Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No); Fatty degeneration (expressed as Yes or No).

Outcome measures

Measure	Golimumab Injection n=13 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
Percentage of Participants Without MRI Inflammatory Lesions in the Left Hip at 12 Months of Follow-up	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months from the baseline

Percentage of participants without US Inflammatory Lesions in the Right Hip at 6 months of follow-up based on result available and suitable for paired analysis.

There were no standardized US scores available for hips at the time of study initiation. Information on hip(s) US was collected for patients based on availability in the patient charts: Joint effusion (expressed as Yes or No); Distance between lower margin of femoral neck and lower part of joint capsule expressed in millimeters; Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No).

Outcome measures

Measure	Golimumab Injection n=21 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
Percentage of Participants Without US Inflammatory Lesions in the Right Hip at 6 Months of Follow-up	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months from the baseline

Percentage of participants without US Inflammatory Lesions in the Left Hip at 6 months of follow-up based on result available and suitable for paired analysis.

There were no standardized US scores available for hips at the time of study initiation. Information on hip(s) US was collected for patients based on availability in the patient charts: Joint effusion (expressed as Yes or No); Distance between lower margin of femoral neck and lower part of joint capsule expressed in millimeters; Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No).

Outcome measures

Measure	Golimumab Injection n=21 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
Percentage of Participants Without US Inflammatory Lesions in the Left Hip at 6 Months of Follow-up	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months from the baseline

Percentage of participants without US Inflammatory Lesions in the Right Hip at 12 months of follow-up based on result available and suitable for paired analysis.

There were no standardized US scores available for hips at the time of study initiation. Information on hip(s) US was collected for patients based on availability in the patient charts: Joint effusion (expressed as Yes or No); Distance between lower margin of femoral neck and lower part of joint capsule expressed in millimeters; Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No).

Outcome measures

Measure	Golimumab Injection n=18 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
Percentage of Participants Without US Inflammatory Lesions in the Right Hip at 12 Months of Follow-up	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months from the baseline

Percentage of participants without US Inflammatory Lesions in the Left Hip at 12 months of follow-up based on result available and suitable for paired analysis.

There were no standardized US scores available for hips at the time of study initiation. Information on hip(s) US was collected for patients based on availability in the patient charts: Joint effusion (expressed as Yes or No); Distance between lower margin of femoral neck and lower part of joint capsule expressed in millimeters; Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No).

Outcome measures

Measure	Golimumab Injection n=18 Participants Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
Percentage of Participants Without US Inflammatory Lesions in the Left Hip at 12 Months of Follow-up	11 Participants

Adverse Events

Golimumab Injection

Serious events: 3 serious events

Other events: 12 other events

Deaths: 1 deaths

Serious adverse events

Measure	Golimumab Injection n=39 participants at risk Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
Injury, poisoning and procedural complications Alcohol intoxication	2.6% 1/39 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	2.6% 1/39 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cyst	2.6% 1/39 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.

Other adverse events

Measure	Golimumab Injection n=39 participants at risk Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
Respiratory, thoracic and mediastinal disorders Acute respiratory viral infection	10.3% 4/39 • Number of events 5 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Respiratory, thoracic and mediastinal disorders Bronchitis	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
General disorders Headache	2.6% 1/39 • Number of events 2 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Gastrointestinal disorders Diarrhea	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Eye disorders Conjunctivitis	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
General disorders Fever	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Gastrointestinal disorders Alanine aminotransferase (ALT) level increased	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Gastrointestinal disorders Aspartate transaminase (AST) level increased	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Eye disorders Eye pain	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Reproductive system and breast disorders Pain in the breast	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Musculoskeletal and connective tissue disorders Pain in metatarsophalangeal joints	2.6% 1/39 • Number of events 2 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Musculoskeletal and connective tissue disorders Pain in hip joint	2.6% 1/39 • Number of events 3 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Gastrointestinal disorders Pain in epigastric region	2.6% 1/39 • Number of events 2 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Musculoskeletal and connective tissue disorders Pain in gluteal region	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Reproductive system and breast disorders Discharges from genital tract	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Skin and subcutaneous tissue disorders Itching in genital area	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Respiratory, thoracic and mediastinal disorders Deflection of nasal septum	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Reproductive system and breast disorders Colpitis	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Infections and infestations Latent tuberculosis infection	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Blood and lymphatic system disorders Leukopenia	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Infections and infestations Mycoplasmosis	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Gastrointestinal disorders Loose stool	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Gastrointestinal disorders Vomiting	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
General disorders Fatigue	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Eye disorders Watery eyes	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Gastrointestinal disorders Nausea	5.1% 2/39 • Number of events 2 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Infections and infestations Ureaplasmosis	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
Reproductive system and breast disorders Endometriosis	2.6% 1/39 • Number of events 1 • Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.

Additional Information

Vladimir Achikyan

MSD Pharmaceuticals LLC

Phone: +74959167100

Email: vladimir.achikyan@merck.com

Results disclosure agreements

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