Trial Outcomes & Findings for Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial (NCT NCT01400516)
NCT ID: NCT01400516
Last Updated: 2017-04-11
Results Overview
Both hands were scanned using a CT scanner. A semi-automated software tool was used to segment the erosion margins in 3D. A board certified radiologist identified the individual erosions in six sub-regions: radius, ulna, proximal carpals, distal carpals, metacarpophalangeal (MCP) joints and proximal interphalangeal (PIP) joints. The average total in a single hand/wrist was calculated. A negative change from Baseline(less joint erosions) indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
Baseline and Month 12
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
Control Arm
The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
|
Teriparatide
The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
|
|---|---|---|
|
Primary Trial
STARTED
|
12
|
14
|
|
Primary Trial
COMPLETED
|
12
|
12
|
|
Primary Trial
NOT COMPLETED
|
0
|
2
|
|
Extension Trial
STARTED
|
6
|
7
|
|
Extension Trial
COMPLETED
|
6
|
7
|
|
Extension Trial
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Control Arm
The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
|
Teriparatide
The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
|
|---|---|---|
|
Primary Trial
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial
Baseline characteristics by cohort
| Measure |
Control Arm
n=12 Participants
The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
|
Teriparatide
n=12 Participants
The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=99 Participants
|
63 years
n=107 Participants
|
62 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
Both hands were scanned using a CT scanner. A semi-automated software tool was used to segment the erosion margins in 3D. A board certified radiologist identified the individual erosions in six sub-regions: radius, ulna, proximal carpals, distal carpals, metacarpophalangeal (MCP) joints and proximal interphalangeal (PIP) joints. The average total in a single hand/wrist was calculated. A negative change from Baseline(less joint erosions) indicates improvement.
Outcome measures
| Measure |
Control Arm
n=12 Participants
The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
|
Teriparatide
n=12 Participants
The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
|
|---|---|---|
|
Change From Baseline in Joint Erosion Volume Measured by 3-Dimensional Computed Tomography (3D CT) Scan
Baseline
|
571.4 cubic millimeter (mm^3)
Interval 160.0 to 1341.6
|
369.8 cubic millimeter (mm^3)
Interval 171.0 to 1163.9
|
|
Change From Baseline in Joint Erosion Volume Measured by 3-Dimensional Computed Tomography (3D CT) Scan
Change from Baseline at Month 12
|
9.1 cubic millimeter (mm^3)
Interval -29.6 to 26.4
|
-0.4 cubic millimeter (mm^3)
Interval -34.5 to 29.6
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
BMD was measured at the lumbosacral spine antero-posterior and at the femoral neck using a densitometer. A positive change from Baseline (increased bone density) indicates improvement.
Outcome measures
| Measure |
Control Arm
n=12 Participants
The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
|
Teriparatide
n=12 Participants
The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
|
|---|---|---|
|
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) and Instant Vertebral Assessment (IVA) Scan
Spine, Baseline
|
0.93 grams/centimeters squared (g/cm^2)
Standard Deviation 0.11
|
0.91 grams/centimeters squared (g/cm^2)
Standard Deviation 0.09
|
|
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) and Instant Vertebral Assessment (IVA) Scan
Spine, Change from Baseline at Month12
|
-0.002 grams/centimeters squared (g/cm^2)
Standard Deviation 0.11
|
0.06 grams/centimeters squared (g/cm^2)
Standard Deviation 0.04
|
|
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) and Instant Vertebral Assessment (IVA) Scan
Femoral neck, Baseline
|
0.73 grams/centimeters squared (g/cm^2)
Standard Deviation 0.09
|
0.68 grams/centimeters squared (g/cm^2)
Standard Deviation 0.06
|
|
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) and Instant Vertebral Assessment (IVA) Scan
Femoral neck, Change from Baseline at Month 12
|
-0.03 grams/centimeters squared (g/cm^2)
Standard Deviation 0.08
|
0.03 grams/centimeters squared (g/cm^2)
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and C-Reactive Protein (CRP) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Control Arm
n=12 Participants
The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
|
Teriparatide
n=12 Participants
The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
|
|---|---|---|
|
Change From Baseline in Disease Activity Score 28 Joint Count C-Reactive Protein (DAS-28 CRP)
Baseline
|
2.73 score on a scale
Standard Deviation 1.19
|
2.66 score on a scale
Standard Deviation 1.43
|
|
Change From Baseline in Disease Activity Score 28 Joint Count C-Reactive Protein (DAS-28 CRP)
Change from Baseline at Month 12
|
-0.50 score on a scale
Standard Deviation 0.67
|
0.42 score on a scale
Standard Deviation 0.67
|
Adverse Events
Control Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Teriparatide
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Arm
n=12 participants at risk
The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
|
Teriparatide
n=12 participants at risk
The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
8.3%
1/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
Other adverse events
| Measure |
Control Arm
n=12 participants at risk
The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
|
Teriparatide
n=12 participants at risk
The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
1/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
8.3%
1/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
|
Skin and subcutaneous tissue disorders
Hair lost
|
0.00%
0/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
16.7%
2/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
|
Investigations
High serum calcium
|
0.00%
0/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
8.3%
1/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
0.00%
0/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
8.3%
1/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
16.7%
2/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
|
Musculoskeletal and connective tissue disorders
Pain in knees and ankles
|
0.00%
0/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
8.3%
1/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
|
Gastrointestinal disorders
Stomach pain
|
8.3%
1/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
0.00%
0/12 • Up to 2 Years
Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place