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Trial Outcomes & Findings for Seronegative Oligoarthritis of the Knee Study (SOKS) (NCT NCT01216631)

NCT ID: NCT01216631

Last Updated: 2016-05-13

Results Overview

reduction of ultrasound synovitis score of the affected knee at 8 weeks following intiation of treatment

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

8 weeks

Results posted on

2016-05-13

Participant Flow

Participant milestones

Participant milestones
Measure
IA Steroid
Intra-articular injection of steroid (80mg depomedrone) methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)
IA Infliximab
intra-articular injection of 100mg infliximab Infliximab: intra-articular injection of 100mg infliximab given at baseline only
IV Infliximab
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 Study
STARTED
0
0
1
Overall Study
COMPLETED
0
0
1
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Seronegative Oligoarthritis of the Knee Study (SOKS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
IA Steroid
Intra-articular injection of steroid (80mg depomedrone) methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)
IA Infliximab
intra-articular injection of 100mg infliximab Infliximab: intra-articular injection of 100mg infliximab given at baseline only
IV Infliximab
n=1 Participants
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
n=1 Participants
Total of all reporting groups
Age, Categorical
<=18 years
—
—
0 participants
n=206 Participants
0 participants
n=7 Participants
Age, Categorical
Between 18 and 65 years
—
—
1 participants
n=206 Participants
1 participants
n=7 Participants
Age, Categorical
>=65 years
—
—
0 participants
n=206 Participants
0 participants
n=7 Participants
Gender
Female
—
—
0 participants
n=206 Participants
0 participants
n=7 Participants
Gender
Male
—
—
1 participants
n=206 Participants
1 participants
n=7 Participants
Region of Enrollment
United Kingdom
—
—
1 participants
n=206 Participants
1 participants
n=7 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: 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.

reduction of ultrasound synovitis score of the affected knee at 8 weeks following intiation of treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Change in patient's assessment of pain by a 100mm visual analogue score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Change in PsQOL score from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks

Change in RAOS questionnaire score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Change in patient's assessment of pain by a 100mm visual analogue score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Change in patient's assessment of pain by a 100mm visual analogue score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 weeks

Change in patient's assessment of pain by a 100mm visual analogue score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

Change in patient's assessment of pain by a 100mm visual analogue score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 26 weeks

Change in PsQOL score from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Change in PsQOL score from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Change in PsQOL score from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 weeks

Change in PsQOL score from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

Change in PsQOL score from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 26 weeks

Change in PsQOL score from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Change in RAOS questionnaire score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Change in RAOS questionnaire score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 weeks

Change in RAOS questionnaire score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

Change in RAOS questionnaire score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 26 weeks

Change in RAOS questionnaire score

Outcome measures

Outcome data not reported

Adverse Events

IA Steroid

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

IA Infliximab

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

IV Infliximab

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Philip Conaghan

University of Leeds

Phone: +44 113 3924884

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place