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Trial record 6 of 14 for:    "Spinal Disease" | "Methylprednisolone"

Seronegative Oligoarthritis of the Knee Study (SOKS) (SOKS)

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ClinicalTrials.gov Identifier: NCT01216631
Recruitment Status : Terminated (Unable to recruit)
First Posted : October 7, 2010
Results First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Laura Coates, University of Leeds

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Spondylarthropathies
Interventions Drug: methylprednisolone
Drug: Infliximab
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IA Steroid IA Infliximab IV Infliximab
Hide Arm/Group Description

Intra-articular injection of steroid (80mg depomedrone)

methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)

intra-articular injection of 100mg infliximab

Infliximab: intra-articular injection of 100mg infliximab given at baseline only

intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)

Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14

Period Title: Overall Study
Started 0 0 1
Completed 0 0 1
Not Completed 0 0 0
Arm/Group Title IA Steroid IA Infliximab IV Infliximab Total
Hide Arm/Group Description

Intra-articular injection of steroid (80mg depomedrone)

methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)

intra-articular injection of 100mg infliximab

Infliximab: intra-articular injection of 100mg infliximab given at baseline only

intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)

Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14

Total of all reporting groups
Overall Number of Baseline Participants 0 0 1 1
Hide Baseline Analysis Population Description
Only 1 recruited
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 1 participants 1 participants
<=18 years 0 0
Between 18 and 65 years 1 1
>=65 years 0 0
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 1 participants 1 participants
Female 0 0
Male 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 0 participants 0 participants 1 participants 1 participants
1 1
1.Primary Outcome
Title Ultrasound Synovitis Score
Hide Description reduction of ultrasound synovitis score of the affected knee at 8 weeks following intiation of treatment
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient was recruited for this study due to problems with recruitment. Therefore outcome measure data is not analysed as only one patient was recruited.
Arm/Group Title IA Steroid IA Infliximab IV Infliximab
Hide Arm/Group Description:

Intra-articular injection of steroid (80mg depomedrone)

methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)

intra-articular injection of 100mg infliximab

Infliximab: intra-articular injection of 100mg infliximab given at baseline only

intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)

Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title US Synovitis Score
Hide Description Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation
Time Frame 2 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Pain Visual Analogue Scale
Hide Description Change in patient's assessment of pain by a 100mm visual analogue score
Time Frame 2 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Psoriatic Arthritis Quality of Life Scale (PsQOL)
Hide Description Change in PsQOL score from baseline
Time Frame 2 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Rheumatoid Arthritis Outcome Score (RAOS)
Hide Description Change in RAOS questionnaire score
Time Frame 2 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title US Synovitis Score
Hide Description Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation
Time Frame 16 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Pain Visual Analogue Scale
Hide Description Change in patient's assessment of pain by a 100mm visual analogue score
Time Frame 6 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Pain Visual Analogue Scale
Hide Description Change in patient's assessment of pain by a 100mm visual analogue score
Time Frame 8 weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Pain Visual Analogue Scale
Hide Description Change in patient's assessment of pain by a 100mm visual analogue score
Time Frame 14 weeks
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Pain Visual Analogue Scale
Hide Description Change in patient's assessment of pain by a 100mm visual analogue score
Time Frame 16 weeks
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Psoriatic Arthritis Quality of Life Scale (PsQOL)
Hide Description Change in PsQOL score from baseline
Time Frame 26 weeks
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Psoriatic Arthritis Quality of Life Scale (PsQOL)
Hide Description Change in PsQOL score from baseline
Time Frame 6 weeks
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Psoriatic Arthritis Quality of Life Scale (PsQOL)
Hide Description Change in PsQOL score from baseline
Time Frame 8 weeks
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Psoriatic Arthritis Quality of Life Scale (PsQOL)
Hide Description Change in PsQOL score from baseline
Time Frame 14 weeks
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Psoriatic Arthritis Quality of Life Scale (PsQOL)
Hide Description Change in PsQOL score from baseline
Time Frame 16 weeks
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Psoriatic Arthritis Quality of Life Scale (PsQOL)
Hide Description Change in PsQOL score from baseline
Time Frame 26 weeks
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Rheumatoid Arthritis Outcome Score (RAOS)
Hide Description Change in RAOS questionnaire score
Time Frame 6 weeks
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Rheumatoid Arthritis Outcome Score (RAOS)
Hide Description Change in RAOS questionnaire score
Time Frame 8 weeks
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Rheumatoid Arthritis Outcome Score (RAOS)
Hide Description Change in RAOS questionnaire score
Time Frame 14 weeks
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Rheumatoid Arthritis Outcome Score (RAOS)
Hide Description Change in RAOS questionnaire score
Time Frame 16 weeks
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Rheumatoid Arthritis Outcome Score (RAOS)
Hide Description Change in RAOS questionnaire score
Time Frame 26 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IA Steroid IA Infliximab IV Infliximab
Hide Arm/Group Description

Intra-articular injection of steroid (80mg depomedrone)

methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)

intra-articular injection of 100mg infliximab

Infliximab: intra-articular injection of 100mg infliximab given at baseline only

intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)

Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14

All-Cause Mortality
IA Steroid IA Infliximab IV Infliximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IA Steroid IA Infliximab IV Infliximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IA Steroid IA Infliximab IV Infliximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Philip Conaghan
Organization: University of Leeds
Phone: +44 113 3924884
EMail: p.conaghan@leeds.ac.uk
Layout table for additonal information
Responsible Party: Laura Coates, University of Leeds
ClinicalTrials.gov Identifier: NCT01216631     History of Changes
Other Study ID Numbers: 2009-015810-23
First Submitted: October 6, 2010
First Posted: October 7, 2010
Results First Submitted: May 26, 2015
Results First Posted: May 13, 2016
Last Update Posted: May 13, 2016