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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02186873




Registration number
NCT02186873
Ethics application status
Date submitted
8/07/2014
Date registered
10/07/2014
Date last updated
22/12/2017

Titles & IDs
Public title
A Study of Golimumab in Participants With Active Ankylosing Spondylitis
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing Spondylitis
Secondary ID [1] 0 0
CNTO148AKS3001
Secondary ID [2] 0 0
CR103795
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Golimumab

Experimental: Treatment Group 1: Placebo then Golimumab - Participants will receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Weeks 16, 20 and thereafter every 8 weeks up to Week 52.

Experimental: Treatment Group 2: Golimumab - Participants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 16, participants will receive a placebo infusion to maintain the blind.


Treatment: Drugs: Placebo
Participants will receive matching placebo.

Treatment: Drugs: Golimumab
Participants will receive 2mg/kg of intravenous infusions of golimumab .

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16 - 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.
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16 - 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.
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16 - 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.
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16 - 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.
Timepoint [3] 0 0
Baseline and Week 16
Secondary outcome [4] 0 0
Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16 - 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.
Timepoint [4] 0 0
Baseline and Week 16
Secondary outcome [5] 0 0
Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16 - 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.
Timepoint [5] 0 0
Baseline and Week 16
Secondary outcome [6] 0 0
Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16 - 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.
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16 - 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.
Timepoint [7] 0 0
Baseline and Week 16
Secondary outcome [8] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16 - 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.
Timepoint [8] 0 0
Baseline and Week 16

Eligibility
Key inclusion criteria
- Participants with diagnosis of definite ankylosing spondylitis for at least 3 months
based on modified New York radiographic and clinical criteria

- Participants with symptoms of active disease at screening and at baseline

- Participant has either an inadequate response to at least 2 non-steroidal
anti-inflammatory drugs (NSAID) over a 4 week period in total with maximal recommended
doses of NSAIDs, or is unable to receive a full 4 weeks of maximal NSAID therapy
because of intolerance, toxicity, or contraindications to NSAIDs

- Participants with C- reactive protein (CRP) level of greater than or equal to (>=) 0.3
milligram per deciliter (mg/dL) at screening

- Additional protocol-defined inclusion criteria apply
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant with other inflammatory diseases that might confound the evaluations of
benefit from the golimumab therapy

- Pregnant or lactating females

- Participants with chest radiograph within 3 months prior to the first administration
of study agent that shows an abnormality suggestive of a malignancy or current active
infection, including tuberculosis

- Participants who had a serious infection (including but not limited to, hepatitis,
pneumonia, sepsis, or pyelonephritis), or have been hospitalized for an infection, or
have been treated with intravenous (IV) antibiotics for an infection within 2 months
prior to first administration of study agent

- Additional protocol-defined exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Maroochydore
Recruitment postcode(s) [1] 0 0
- Maroochydore
Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Indiana
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United States of America
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Missouri
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New York
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North Carolina
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Ohio
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Pennsylvania
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United States of America
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Texas
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Canada
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Newfoundland and Labrador
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Canada
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Burlington
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Canada
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Trois-Rivieres
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Germany
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Bad Doberan
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Germany
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Berlin
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Germany
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Erfurt
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Germany
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Hamburg
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Germany
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Planegg
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Germany
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Ratingen
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Germany
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Zerbst
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Korea, Republic of
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Ansan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Seongdong-Gu
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Korea, Republic of
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Seoul
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Mexico
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Chihuahua
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Poland
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Bydgoszcz
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Poland
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Bytom
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Poland
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Nadarzyn
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Poland
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Nowa Sól
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Poland
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Poznan
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Poland
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Warszawa
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Smolensk
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Russian Federation
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Tver
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Ukraine
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Chernihiv
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kyiv
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Ukraine
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Odessa
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Ukraine
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Vinnytsia
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Ukraine
State/province [43] 0 0
Zaporizhzhia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy of intravenously (administration of a
fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants
with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that
involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral
joints).
Trial website
https://clinicaltrials.gov/show/NCT02186873
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications