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

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ClinicalTrials.gov Identifier: NCT01668004
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : August 3, 2016
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Intervention Biological: Golimumab
Enrollment 101

Recruitment Details  
Pre-assignment Details A total of 104 participants were screened; 3 participants were screen failures who did not enroll.
Arm/Group Title GLM 50 mg
Hide Arm/Group Description Golimumab (GLM) given subcutaneously at a dose of 50 mg once monthly for up to 12 months
Period Title: Overall Study
Started 101
Treated 101
Completed 76
Not Completed 25
Reason Not Completed
Adverse Event             7
Withdrawal by Subject             2
Lost to Follow-up             5
Lack of Efficacy             9
Non-compliance with treatment             2
Arm/Group Title GLM 50 mg
Hide Arm/Group Description GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
Overall Number of Baseline Participants 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
44.4  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Female
35
  34.7%
Male
66
  65.3%
Time since diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
10.8  (11.8)
Age at onset of disease  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
33.1  (11.8)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 101 participants
175.82  (9.62)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 101 participants
82.63  (18.00)
Abdominal circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 101 participants
95.5  (15.5)
1.Primary Outcome
Title Occurence Rate of Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment
Hide Description 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.
Time Frame Twelve Months Prior to Enrollment to Study Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (occurence of uveitis).
Arm/Group Title Before Initial Anti-TNF/GLM Treatment After GLM Treatment Start
Hide Arm/Group Description:
Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
Overall Number of Participants Analyzed 93 93
Measure Type: Number
Unit of Measure: Ratio
0.08 0.08
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Before Initial Anti-TNF/GLM Treatment, After GLM Treatment Start
Comments Treatment comparison of uveitis occurrence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=93.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
2.Primary Outcome
Title Annual Incidence Rate of New Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment
Hide Description 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 period entry, participants did not have the same risk of new events during the one year periods. Participants with ongoing uveitis at start of GLM who had the adverse event for the entire treatment period were counted as having the 'new attack' before and no “new attack” after GLM treatment start.
Time Frame Twelve Months Prior to Enrollment to Study Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (incidence of uveitis). One participant for whom the timing of uveitis events could not be determined was excluded from the analysis.
Arm/Group Title Before Initial Anti-TNF/GLM Treatment After GLM Treatment Start
Hide Arm/Group Description:
Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
Overall Number of Participants Analyzed 92 92
Measure Type: Number
Unit of Measure: Events per 100 participant years
9.8 2.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Before Initial Anti-TNF/GLM Treatment, After GLM Treatment Start
Comments Treatment difference (expressed as ratio) in uveitis incidence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=92.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Generalized estimating equation
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Ratio
Estimated Value 4.50
Confidence Interval (2-Sided) 95%
3.86 to 5.25
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Annual Incidence Rate of New-Onset or Flares of Inflammatory Bowel Disease (IBD) and Psoriasis in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment
Hide Description IBD (Crohn's disease or ulcerative colitis) and psoriaris are extra-articular manifestations of AS involving the intestinal tract and skin, respectively. The annual incidence rates of new-onset or flares of IBD and psoriasis were to be determined separately (i.e., for each condition) 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.
Time Frame Twelve Months Prior to Enrollment to Study Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The incidence rates for new onset or flares of IBD and psoriasis could not be evaluated due to limitations of the data collected; occurrence of flares was not collected (specifically, history of IBD and/or psoriasis could not be distinguished from flares of IBD and/or psoriasis) and, therefore, results could not be determined.
Arm/Group Title Before Initial Anti-TNF/GLM Treatment After GLM Treatment Start
Hide Arm/Group Description:
Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percentage of Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) Responders Following Treatment With GLM
Hide Description 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 with the scores for the remaining four items resulting in a composite score (0-50); the final BASDAI score (0-10) is derived by dividing by 5.
Time Frame Baseline (BL), Study Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (BASDAI 50).
Arm/Group Title GLM 50 mg
Hide Arm/Group Description:
GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
Overall Number of Participants Analyzed 88
Measure Type: Number
Unit of Measure: Percentage of participants
33.0
5.Secondary Outcome
Title Percentage of Ankylosing Spondylitis Disease Activity Score (ASDAS) Responders Following Treatment With GLM
Hide Description 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 + 0.06*Duration of Morning Stiffness + 0.11*Patient Global + 0.07*Peripheral Pain/Swelling + 0.58*ln(CRP (mg/L) +1). A decrease in ASDAS at 3 months relative to BL signifies an improvement in physical function; ASDAS-MI (≥ 2.0 units decrease from BL) signifies a comparatively greater improvement in physical function than ASDAS-CII (≥ 1.1 units decrease from BL).
Time Frame BL, Study Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (ASDAS).
Arm/Group Title GLM 50 mg
Hide Arm/Group Description:
GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
Overall Number of Participants Analyzed 84
Measure Type: Number
Unit of Measure: Percentage of participants
ASDAS-CII (≥ 1.1 units) 40.5
ASDAS-MI (≥ 2.0 units) 19.0
Time Frame Up to one year
Adverse Event Reporting Description All safety analyses were performed on the All Treated Set, defined as all patients who received at least one dose of golimumab in the study. Only safety data during the GLM period was collected.
 
Arm/Group Title GLM 50 mg
Hide Arm/Group Description GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
All-Cause Mortality
GLM 50 mg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GLM 50 mg
Affected / at Risk (%) # Events
Total   7/101 (6.93%)    
Cardiac disorders   
Acute Coronary Syndrome  1  1/101 (0.99%)  1
Cardiac Failure  1  1/101 (0.99%)  1
Gastrointestinal disorders   
Colitis Ulcerative  1  1/101 (0.99%)  1
Large Intestinal Ulcer Haemorrhage  1  1/101 (0.99%)  1
Infections and infestations   
Cellulitis  1  1/101 (0.99%)  1
Pneumonia  1  1/101 (0.99%)  1
Urinary Tract Infection  1  1/101 (0.99%)  1
Infection  1  1/101 (0.99%)  1
Musculoskeletal and connective tissue disorders   
Bursitis  1  1/101 (0.99%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Prostate Cancer  1  1/101 (0.99%)  1
Surgical and medical procedures   
Fistula Repair  1  1/101 (0.99%)  1
Vascular disorders   
Hypovolaemic shock  1  1/101 (0.99%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GLM 50 mg
Affected / at Risk (%) # Events
Total   21/101 (20.79%)    
Infections and infestations   
Nasopharyngitis  1  11/101 (10.89%)  12
Nervous system disorders   
Headache  1  13/101 (12.87%)  19
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to proprietary information, accuracy of information, and regulatory compliance.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01668004     History of Changes
Other Study ID Numbers: 8259-012
2012-002458-21 ( EudraCT Number )
First Submitted: August 1, 2012
First Posted: August 17, 2012
Results First Submitted: April 15, 2016
Results First Posted: August 3, 2016
Last Update Posted: April 11, 2017