Trial Outcomes & Findings for Differences in Bone Cell Activity Between Rheumatoid Arthritis and Ankylosing Spondylitis (NCT NCT01417455)
NCT ID: NCT01417455
Last Updated: 2016-03-21
Results Overview
Osteoclasts will be differentiated from untreated patients and patients under several TNF blockers.
Recruitment status
COMPLETED
Target enrollment
101 participants
Primary outcome timeframe
at baseline and at 6 months
Results posted on
2016-03-21
Participant Flow
Patients with RA and AS were recruited from the Rheumatology and Bone Metabolic Disease Department, Hospital de Santa Maria, Lisbon Academic Medical Centre, Portugal from May 2011 to May 2014. Healthy donors were recruited among the Hospital and research centre personnel.
Aparent discrepancy of Enrollment number (101) and Participant Flow module (147) derive from patient follow-up. Patients enrolled were 101. 16 RA were followed up on the RA with DMARDs cohort. 17 RA baseline for TNF-blockers were followed up in the RA with TNF blockers. 13 AS baseline for TNF-blockers were followed up in the AS with TNF blockers.
Participant milestones
| Measure |
Rheumatoid Arthritis
Active Rheumatoid Arthritis patients
|
Rheumatoid Arthritis With DMARDs
Patients that started DMARD therapy after the Baseline collection
|
Rheumatoid Arthritis Baseline for TNF-blockers
RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
|
Rheumatoid Arthritis With TNF-blockers
RA patients recruited at least 6 months after the start of a TNF-blocker
|
Ankylosing Spondylitis
Active Ankylosing Spondylitis
|
Ankylosing Spondylitis Baseline for TNF Blocker
Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
|
Ankylosing Spondylitis With TNF-blockers
Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
|
Controls
Healthy donors age and sex matched to the patients
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
17
|
17
|
30
|
13
|
13
|
25
|
|
Overall Study
COMPLETED
|
16
|
16
|
17
|
17
|
30
|
13
|
13
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Differences in Bone Cell Activity Between Rheumatoid Arthritis and Ankylosing Spondylitis
Baseline characteristics by cohort
| Measure |
Rheumatoid Arthritis
n=16 Participants
Active Rheumatoid Arthritis patients
|
Rheumatoid Arthritis With DMARDs
n=16 Participants
Patients that started DMARD therapy after the Baseline collection
|
Rheumatoid Arthritis Baseline for TNF-blockers
n=17 Participants
RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
|
Rheumatoid Arthritis With TNF-blockers
n=17 Participants
RA patients recruited at least 6 months after the start of a TNF-blocker
|
Ankylosing Spondylitis
n=30 Participants
Active Ankylosing Spondylitis
|
Ankylosing Spondylitis Baseline for TNF Blocker
n=13 Participants
Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
|
Ankylosing Spondylitis With TNF-blockers
n=13 Participants
Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
|
Controls
n=25 Participants
Healthy donors age and sex matched to the patients
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
50 years
n=7 Participants
|
50 years
n=5 Participants
|
50 years
n=4 Participants
|
40 years
n=21 Participants
|
37 years
n=8 Participants
|
37 years
n=8 Participants
|
45 years
n=24 Participants
|
45 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
80 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
67 Participants
n=42 Participants
|
|
Disease activity
|
4.7 units on a scale
n=5 Participants
|
2.4 units on a scale
n=7 Participants
|
5.7 units on a scale
n=5 Participants
|
2.9 units on a scale
n=4 Participants
|
5.8 units on a scale
n=21 Participants
|
3.8 units on a scale
n=8 Participants
|
1.7 units on a scale
n=8 Participants
|
NA units on a scale
n=24 Participants
|
NA units on a scale
n=42 Participants
|
|
ESR (mm/hr)
|
22 mm/hr
n=5 Participants
|
13 mm/hr
n=7 Participants
|
25 mm/hr
n=5 Participants
|
21 mm/hr
n=4 Participants
|
23 mm/hr
n=21 Participants
|
30 mm/hr
n=8 Participants
|
7 mm/hr
n=8 Participants
|
NA mm/hr
n=24 Participants
|
NA mm/hr
n=42 Participants
|
|
CRP (mg/dl)
|
0.3 mg/dl
n=5 Participants
|
0.2 mg/dl
n=7 Participants
|
1.4 mg/dl
n=5 Participants
|
0.3 mg/dl
n=4 Participants
|
0.8 mg/dl
n=21 Participants
|
1.4 mg/dl
n=8 Participants
|
0.1 mg/dl
n=8 Participants
|
NA mg/dl
n=24 Participants
|
NA mg/dl
n=42 Participants
|
|
Symptoms duration (years)
|
0.8 years
n=5 Participants
|
1.3 years
n=7 Participants
|
6 years
n=5 Participants
|
7 years
n=4 Participants
|
11 years
n=21 Participants
|
10 years
n=8 Participants
|
11 years
n=8 Participants
|
NA years
n=24 Participants
|
NA years
n=42 Participants
|
PRIMARY outcome
Timeframe: at baseline and at 6 monthsOsteoclasts will be differentiated from untreated patients and patients under several TNF blockers.
Outcome measures
| Measure |
Rheumatoid Arthritis
n=16 Participants
Active Rheumatoid Arthritis patients
|
Rheumatoid Arthritis With DMARDs
n=16 Participants
Patients that started DMARD therapy after the Baseline collection
|
Rheumatoid Arthritis Baseline for TNF-blockers
n=17 Participants
RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
|
Rheumatoid Arthritis With TNF-blockers
n=17 Participants
RA patients recruited at least 6 months after the start of a TNF-blocker
|
Ankylosing Spondylitis
n=23 Participants
Active Ankylosing Spondylitis
|
Ankylosing Spondylitis Baseline for TNF Blocker
n=13 Participants
Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
|
Ankylosing Spondylitis With TNF-blockers
n=13 Participants
Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
|
Controls
n=25 Participants
Healthy donors age and sex matched to the patients
|
|---|---|---|---|---|---|---|---|---|
|
Osteoclast Differentiation Ex-vivo
|
8 OC/mm2
Interval 7.0 to 12.0
|
12 OC/mm2
Interval 8.0 to 19.0
|
11 OC/mm2
Interval 4.0 to 21.0
|
5 OC/mm2
Interval 3.0 to 11.0
|
9 OC/mm2
Interval 4.0 to 20.0
|
3 OC/mm2
Interval 1.0 to 5.0
|
5 OC/mm2
Interval 4.0 to 12.0
|
19 OC/mm2
Interval 10.0 to 21.0
|
PRIMARY outcome
Timeframe: at baseline and at 6 monthsTotal area resorbed by osteoclasts as percentage of total area analyzed
Outcome measures
| Measure |
Rheumatoid Arthritis
n=16 Participants
Active Rheumatoid Arthritis patients
|
Rheumatoid Arthritis With DMARDs
n=16 Participants
Patients that started DMARD therapy after the Baseline collection
|
Rheumatoid Arthritis Baseline for TNF-blockers
n=17 Participants
RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
|
Rheumatoid Arthritis With TNF-blockers
n=17 Participants
RA patients recruited at least 6 months after the start of a TNF-blocker
|
Ankylosing Spondylitis
n=23 Participants
Active Ankylosing Spondylitis
|
Ankylosing Spondylitis Baseline for TNF Blocker
n=13 Participants
Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
|
Ankylosing Spondylitis With TNF-blockers
n=13 Participants
Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
|
Controls
n=25 Participants
Healthy donors age and sex matched to the patients
|
|---|---|---|---|---|---|---|---|---|
|
Osteoclast Activity Ex-vivo
|
39 percentage of resorbed area
Interval 21.0 to 75.0
|
11 percentage of resorbed area
Interval 0.0 to 80.0
|
4 percentage of resorbed area
Interval 3.0 to 16.0
|
0.6 percentage of resorbed area
Interval 0.3 to 4.0
|
16 percentage of resorbed area
Interval 2.0 to 27.0
|
2 percentage of resorbed area
Interval 0.0 to 3.0
|
10 percentage of resorbed area
Interval 6.0 to 24.0
|
10 percentage of resorbed area
Interval 0.0 to 38.0
|
Adverse Events
Rheumatoid Arthritis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rheumatoid Arthritis With DMARDs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rheumatoid Arthritis Baseline for TNF-blockers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rheumatoid Arthritis With TNF-blockers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ankylosing Spondylitis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ankylosing Spondylitis Baseline for TNF Blocker
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ankylosing Spondylitis With TNF-blockers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place