NCT01668004: GO-EASY

The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012)

Completed Phase 4 Results posted Last updated 4 February 2019

What this trial tests

Phase 4 trial testing Golimumab in Ankylosing Spondylitis in 101 participants. Completed in 30 April 2015.

Timeline

3 September 2012

Primary endpoint
30 April 2015

30 April 2015

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	101
Start date	3 September 2012
Primary completion	30 April 2015
Estimated completion	30 April 2015

Drugs / interventions tested

• Golimumab (GOLIMUMAB) — full drug profile →

Conditions studied

• Ankylosing Spondylitis — all drugs for Ankylosing Spondylitis →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Ankylosing Spondylitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Occurence Rate of Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment Primary · Twelve Months Prior to Enrollment to Study Month 12

Uveitis is an extra-articular manifestation of ankylosing spondylitis (AS) involving inflammation of the eye. The occurrence rate (assessed as present/absent) of uveitis attacks was determined over two 1-year long periods regardless of whether the event started during the assessed year: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose.

Group	Value	95% CI
Before Initial Anti-TNF/GLM Treatment	0.08
After GLM Treatment Start	0.08

Annual Incidence Rate of New Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment Primary · Twelve Months Prior to Enrollment to Study Month 12

Uveitis is an extra-articular manifestation of AS involving inflammation of the eye. The annual incidence rate of new uveitis attacks was determined over two 1-year long periods: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose. All participants were counted as contributing a full year of GLM exposure even if discontinuing early. Due to ongoing uveitis cases at time of per

Group	Value	95% CI
Before Initial Anti-TNF/GLM Treatment	9.8
After GLM Treatment Start	2.2

Percentage of Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) Responders Following Treatment With GLM Secondary · Baseline (BL), Study Month 3

The percentage of participants with a BASDAI 50 response (defined as a 50% improvement or as an absolute improvement of 2 points in their BASDAI physical function score) at three months was determined. The BASDAI consists of total of six visual analog scales (VAS): five VAS (0 to 10 cm; increasing severity) measuring severity of fatigue, spinal pain, peripheral joint pain or swelling, localized tenderness, and severity of morning stiffness and one VAS (0 to 10 cm; increasing duration up to 2 hours) measuring duration of morning stiffness. The morning stiffness scores are averaged and summed wi

Group	Value	95% CI
GLM 50 mg	33.0

Percentage of Ankylosing Spondylitis Disease Activity Score (ASDAS) Responders Following Treatment With GLM Secondary · BL, Study Month 3

The percentage of participants with ASDAS clinically important improvement (ASDAS-CII; ≥ 1.1 units) and major improvement (ASDAS-MI; ≥ 2.0 units) at 3 months were determined. The ASDAS incorporates three items from the BASDAI (spinal pain, duration of morning stiffness, and peripheral joint pain or swelling) each assessed on a VAS (0 to 10 cm; increasing severity) as well as patient global assessment of disease activity (VAS; 0 to 10 cm; increasing severity) and a laboratory measure of inflammation (CRP level \[mg/L\] or ESR \[mm/hr\]). ASDAS was calculated using the formula: 0.12\*Spinal Pain

ASDAS-CII (≥ 1.1 units)

Group	Value	95% CI
GLM 50 mg	40.5

ASDAS-MI (≥ 2.0 units)

Group	Value	95% CI
GLM 50 mg	19.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to one year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GLM 50 mg

Serious: 7/101 (7%)

Deaths: —

Serious adverse events (12 terms)

Reaction	System	GLM 50 mg
Acute Coronary Syndrome	Cardiac disorders	—
Cardiac Failure	Cardiac disorders	—
Colitis Ulcerative	Gastrointestinal disorders	—
Large Intestinal Ulcer Haemorrhage	Gastrointestinal disorders	—
Cellulitis	Infections and infestations	—
Pneumonia	Infections and infestations	—
Urinary Tract Infection	Infections and infestations	—
Bursitis	Musculoskeletal and connective tissue disorders	—
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Fistula Repair	Surgical and medical procedures	—
Hypovolaemic shock	Vascular disorders	—
Infection	Infections and infestations	—

Other adverse events (2 terms — click to expand)

Reaction	System	GLM 50 mg
Headache	Nervous system disorders	—
Nasopharyngitis	Infections and infestations	—

Most-reported serious reactions: Acute Coronary Syndrome, Cardiac Failure, Colitis Ulcerative, Large Intestinal Ulcer Haemorrhage, Cellulitis, Pneumonia, Urinary Tract Infection, Bursitis.

Data from ClinicalTrials.gov NCT01668004 adverse events section.

Sponsor's own description

The objective of this study is to determine the difference in the annual incidence rate of uveitis attacks in participants with ankylosing spondylitis (AS) before start initial anti-TNF therapy and after treatment with golimumab (GLM).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Review of the Landscape of Targeted Immunomodulatory Therapies for Non-Infectious Uveitis.
   Sharma SM, Fu DJ, Xue K. · · 2018 · cited 9× · PMID 29189960 · DOI 10.1007/s40123-017-0115-5