Trial Outcomes & Findings for Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy (NCT NCT00420303)
NCT ID: NCT00420303
Last Updated: 2010-07-20
Results Overview
PGA was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. The normalized net incremental area under the curve of the PGA is the area between the baseline and the PGA curve as a function of time (week 2, 4, 8, 12). AUC was computed using the linear trapezoidal method. All the areas above the baseline and under the curve are positive and all the area below the baseline and above the curve are negative. The net incremental AUC is the sum of these areas. This result is then divided by the study duration of the patients. (negative value = improvement).
COMPLETED
PHASE4
24 participants
12 weeks
2010-07-20
Participant Flow
Patients were recruited worldwide from February 2007 to June 2008.
Patients were screened up to 6 weeks.
Participant milestones
| Measure |
Etanercept
50mg subcutaneously once weekly
|
Placebo
Subcutaneously once weekly
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Etanercept
50mg subcutaneously once weekly
|
Placebo
Subcutaneously once weekly
|
|---|---|---|
|
Overall Study
Serious Adverse Event
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
Baseline characteristics by cohort
| Measure |
Etanercept
n=12 Participants
50mg subcutaneously once weekly
|
Placebo
n=12 Participants
Subcutaneously once weekly
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
34.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
37.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All randomized patients who received at least 1 dose of test article. Last observation carried forward (LOCF)
PGA was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. The normalized net incremental area under the curve of the PGA is the area between the baseline and the PGA curve as a function of time (week 2, 4, 8, 12). AUC was computed using the linear trapezoidal method. All the areas above the baseline and under the curve are positive and all the area below the baseline and above the curve are negative. The net incremental AUC is the sum of these areas. This result is then divided by the study duration of the patients. (negative value = improvement).
Outcome measures
| Measure |
Etanercept
n=12 Participants
50mg subcutaneously once weekly
|
Placebo
n=12 Participants
Subcutaneously once weekly
|
|---|---|---|
|
Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12
|
-28.54 mm
Standard Deviation 18.01
|
-11.07 mm
Standard Deviation 18.01
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: All randomized patients who received at least 1 dose of test article.
The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. Change=12 week score minus baseline score. A negative score indicates an improvement in disease activity and a positive score indicates worsening.
Outcome measures
| Measure |
Etanercept
n=12 Participants
50mg subcutaneously once weekly
|
Placebo
n=12 Participants
Subcutaneously once weekly
|
|---|---|---|
|
Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12
|
-37.59 units on scale
Standard Deviation 22.04
|
-11.58 units on scale
Standard Deviation 22.04
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All randomized patients who received at least 1 dose of test article.
A response is defined as at least a 50% improvement (decrease) from baseline in the patient global assessment of disease activity. The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad.
Outcome measures
| Measure |
Etanercept
n=12 Participants
50mg subcutaneously once weekly
|
Placebo
n=12 Participants
Subcutaneously once weekly
|
|---|---|---|
|
Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity
|
8 patients
|
2 patients
|
Adverse Events
Etanercept
Placebo
Serious adverse events
| Measure |
Etanercept
n=12 participants at risk
50mg subcutaneously once weekly
|
Placebo
n=12 participants at risk
Subcutaneously once weekly
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
8.3%
1/12
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Pharyngolaryngeal pain
|
8.3%
1/12
|
0.00%
0/12
|
Other adverse events
| Measure |
Etanercept
n=12 participants at risk
50mg subcutaneously once weekly
|
Placebo
n=12 participants at risk
Subcutaneously once weekly
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
8.3%
1/12
|
0.00%
0/12
|
|
Eye disorders
Uveitis
|
8.3%
1/12
|
8.3%
1/12
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
2/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12
|
16.7%
2/12
|
|
General disorders
Asthenia
|
8.3%
1/12
|
16.7%
2/12
|
|
General disorders
Fatigue
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Injection site hypersensitivity
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Injection site pruritus
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Injection site reaction
|
8.3%
1/12
|
8.3%
1/12
|
|
General disorders
Malaise
|
0.00%
0/12
|
8.3%
1/12
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12
|
8.3%
1/12
|
|
Infections and infestations
Cellulitis
|
8.3%
1/12
|
0.00%
0/12
|
|
Infections and infestations
Influenza
|
8.3%
1/12
|
0.00%
0/12
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12
|
0.00%
0/12
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/12
|
8.3%
1/12
|
|
Infections and infestations
Rhinitis
|
8.3%
1/12
|
8.3%
1/12
|
|
Infections and infestations
Tracheitis
|
8.3%
1/12
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/12
|
8.3%
1/12
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/12
|
8.3%
1/12
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
8.3%
1/12
|
0.00%
0/12
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12
|
8.3%
1/12
|
|
Nervous system disorders
Headache
|
16.7%
2/12
|
8.3%
1/12
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12
|
0.00%
0/12
|
|
Psychiatric disorders
Restlessness
|
8.3%
1/12
|
0.00%
0/12
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/12
|
8.3%
1/12
|
|
Renal and urinary disorders
Haematuria
|
8.3%
1/12
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
8.3%
1/12
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
8.3%
1/12
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
16.7%
2/12
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/12
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.3%
1/12
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12
|
8.3%
1/12
|
|
Vascular disorders
Hypertension
|
8.3%
1/12
|
8.3%
1/12
|
|
Investigations
Transaminases increased
|
0.00%
0/12
|
8.3%
1/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER