Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 38 for:    "Spinal Disease" | "Benzocaine"

A Study of Golimumab in Participants With Active Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02186873
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : November 13, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Interventions Drug: Placebo
Drug: Golimumab
Enrollment 208
Recruitment Details  
Pre-assignment Details Of the 312 participants screened, 208 participants were randomized (105 to golimumab 2 milligram per kilogram [mg/kg] and 103 to placebo group) and treated.
Arm/Group Title Group 1: Placebo Then Golimumab Group 2: Golimumab
Hide Arm/Group Description Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52. Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
Period Title: Overall Study
Started 103 105
End of Control Period 99 [1] 105 [2]
Completed 94 97
Not Completed 9 8
Reason Not Completed
Adverse Event             1             3
Lack of Efficacy             0             1
Lost to Follow-up             1             2
Withdrawal by Subject             7             2
[1]
Participants taking placebo crossed over to golimumab
[2]
Participants continued to receive golimumab
Arm/Group Title Group 1: Placebo Then Golimumab Group 2: Golimumab Total
Hide Arm/Group Description Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52. Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind. Total of all reporting groups
Overall Number of Baseline Participants 103 105 208
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 105 participants 208 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
102
  99.0%
105
 100.0%
207
  99.5%
>=65 years
1
   1.0%
0
   0.0%
1
   0.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants 105 participants 208 participants
39.2  (10.75) 38.4  (10.11) 38.8  (10.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 105 participants 208 participants
Female
26
  25.2%
19
  18.1%
45
  21.6%
Male
77
  74.8%
86
  81.9%
163
  78.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 103 participants 105 participants 208 participants
Canada 1 1 2
Germany 3 5 8
Mexico 3 3 6
Poland 38 30 68
Russian Federation 16 14 30
South Korea 8 10 18
Ukraine 25 34 59
United States 9 8 17
1.Primary Outcome
Title Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16
Hide Description ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (>=)20% improvement from baseline in at least 3 of the 4 domains: patient’s global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI [0=no functional impairment to 10= maximal impairment]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale [VAS]), and an absence of deterioration (defined as >=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who were randomized in the study.
Arm/Group Title Group 1: Placebo Then Golimumab Group 2: Golimumab
Hide Arm/Group Description:
Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
Overall Number of Participants Analyzed 103 105
Measure Type: Number
Unit of Measure: Percentage of Participants
26.2 73.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: Placebo Then Golimumab, Group 2: Golimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 47.1
Confidence Interval (2-Sided) 95%
35.18 to 58.99
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16
Hide Description An ASAS 40 response is defined as >=40% improvement from baseline in 3 of 4 domains: patient's global assessment of disease activity (0=very well, 10=very poor), total back pain (0=no pain, 10=most severe pain), function (self-assessment using BASFI (0=no functional impairment to 10=maximal impairment), inflammation (0=none, 10=very severe) with an absolute improvement of at least 2 (0-10 cm VAS), and no deterioration in the remaining domain.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized in the study.
Arm/Group Title Group 1: Placebo Then Golimumab Group 2: Golimumab
Hide Arm/Group Description:
Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
Overall Number of Participants Analyzed 103 105
Measure Type: Number
Unit of Measure: Percentage of Participants
8.7 47.6
3.Secondary Outcome
Title Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16
Hide Description The BASDAI is a self-assessment tool to determine disease activity using a VAS of 0-10 cm (0=none and 10=very severe) participant's answered 6 questions measuring fatigue, spinal pain, joint pain, enthesitis, and morning stiffness. The final BASDAI is calculated as a mean of individual questions with a final score range of 0 to 10 cm; 0=best and 10=worst.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized in the study.
Arm/Group Title Group 1: Placebo Then Golimumab Group 2: Golimumab
Hide Arm/Group Description:
Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
Overall Number of Participants Analyzed 103 105
Measure Type: Number
Unit of Measure: Percentage of Participants
14.6 41.0
4.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16
Hide Description The BASFI is a participant's self-assessment of physical function represented as a mean of 10 questions, each question rated on VAS 0 to 10 cm (VAS 0 to 10 cm; 0=easy to 10=impossible), 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life.
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Placebo Then Golimumab Group 2: Golimumab
Hide Arm/Group Description:
Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
Overall Number of Participants Analyzed 98 105
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-0.471  (1.9558) -2.386  (2.1300)
5.Secondary Outcome
Title Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
Hide Description The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score (vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Placebo Then Golimumab Group 2: Golimumab
Hide Arm/Group Description:
Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
Overall Number of Participants Analyzed 98 104
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
2.86  (6.177) 8.52  (7.535)
6.Secondary Outcome
Title Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16
Hide Description The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Placebo Then Golimumab Group 2: Golimumab
Hide Arm/Group Description:
Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
Overall Number of Participants Analyzed 98 104
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.78  (10.004) 6.47  (9.122)
7.Secondary Outcome
Title Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16
Hide Description Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient’s global assessment of disease activity, total back pain, function (BASFI), inflammation.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized in the study.
Arm/Group Title Group 1: Placebo Then Golimumab Group 2: Golimumab
Hide Arm/Group Description:
Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
Overall Number of Participants Analyzed 103 105
Measure Type: Number
Unit of Measure: Percentage of Participants
3.9 16.2
8.Secondary Outcome
Title Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16
Hide Description The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of “yes” on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL.
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Placebo Then Golimumab Group 2: Golimumab
Hide Arm/Group Description:
Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
Overall Number of Participants Analyzed 98 104
Mean (Standard Deviation)
Unit of Measure: Units on Scale
-1.8  (4.57) -5.4  (5.01)
9.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16
Hide Description BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS.
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Group 1: Placebo Then Golimumab Group 2: Golimumab
Hide Arm/Group Description:
Participants received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 participants were crossed over to golimumab and received IV golimumab 2 mg/kg infusions at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
Participants received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Participants received a placebo infusion at Week 16 to maintain the treatment blind.
Overall Number of Participants Analyzed 96 100
Mean (Standard Deviation)
Unit of Measure: Units on Scale
-0.10  (0.539) -0.38  (0.625)
Time Frame Up to 60 weeks
Adverse Event Reporting Description Safety Analysis set included all participants who received at least 1 dose of study drug. Participants who received placebo and crossed over to golimumab were included in placebo then golimumab 2 mg/kg arm and who received at least 1 dose of golimumab were included in placebo then golimumab 2 mg/kg and golimumab 2 mg/kg arms for safety analysis.
 
Arm/Group Title Placebo Placebo Then Golimumab 2 mg/kg Golimumab 2 mg/kg
Hide Arm/Group Description Participants who received placebo only (at least 1 dose) through Week 16. Follow-up was based on the period the participant was receiving placebo (from Week 0) up to the first golimumab 2 mg/kg dose for this treatment group. Participants who received placebo were crossed over to golimumab 2 mg/kg at Week 16. Participants may have also inadvertently received golimumab 2 mg/kg prior to Week 16. Participants may have missed one or more golimumab doses. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group. Participants who inadvertently received golimumab 2 mg/kg prior to Week 16 were applicable to include in this group. Participants who received at least one dose of 2 mg/kg golimumab from Week 0 onward. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group.
All-Cause Mortality
Placebo Placebo Then Golimumab 2 mg/kg Golimumab 2 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Placebo Then Golimumab 2 mg/kg Golimumab 2 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/103 (0.00%)   1/99 (1.01%)   6/105 (5.71%) 
Cardiac disorders       
Sinus tachycardia * 1  0/103 (0.00%)  0/99 (0.00%)  1/105 (0.95%) 
Gastrointestinal disorders       
Pancreatitis * 1  0/103 (0.00%)  0/99 (0.00%)  1/105 (0.95%) 
Hepatobiliary disorders       
Non-alcoholic steatohepatitis * 1  0/103 (0.00%)  0/99 (0.00%)  1/105 (0.95%) 
Infections and infestations       
Appendicitis * 1  0/103 (0.00%)  0/99 (0.00%)  1/105 (0.95%) 
Pneumonia * 1  0/103 (0.00%)  0/99 (0.00%)  1/105 (0.95%) 
Pulmonary tuberculosis * 1  0/103 (0.00%)  0/99 (0.00%)  1/105 (0.95%) 
Injury, poisoning and procedural complications       
Wrist fracture * 1  0/103 (0.00%)  1/99 (1.01%)  0/105 (0.00%) 
Skin and subcutaneous tissue disorders       
Henoch-Schonlein purpura * 1  0/103 (0.00%)  0/99 (0.00%)  1/105 (0.95%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Placebo Then Golimumab 2 mg/kg Golimumab 2 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/103 (2.91%)   16/99 (16.16%)   32/105 (30.48%) 
Infections and infestations       
Nasopharyngitis * 1  1/103 (0.97%)  7/99 (7.07%)  17/105 (16.19%) 
Upper respiratory tract infection * 1  1/103 (0.97%)  3/99 (3.03%)  12/105 (11.43%) 
Investigations       
Alanine aminotransferase increased * 1  0/103 (0.00%)  5/99 (5.05%)  7/105 (6.67%) 
Nervous system disorders       
Headache * 1  1/103 (0.97%)  1/99 (1.01%)  6/105 (5.71%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 19.0
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director Clinical Development, Immunology General
Organization: Johnson&Johnson
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02186873     History of Changes
Other Study ID Numbers: CR103795
CNTO148AKS3001 ( Other Identifier: Janssen Research & Development, LLC )
2014-000241-74 ( EudraCT Number )
First Submitted: July 8, 2014
First Posted: July 10, 2014
Results First Submitted: October 11, 2017
Results First Posted: November 13, 2017
Last Update Posted: December 22, 2017