Trial Outcomes & Findings for The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients (NCT NCT01948388)
NCT ID: NCT01948388
Last Updated: 2019-01-18
Results Overview
To evaluate the effect of the use of 2 doses of corticotrophin (ACTH) as a treatment in patients with early onset rheumatoid arthritis as an alternative to conventional steroid therapy by evaluating the change from baseline in the clinical findings as measured by Clinical Disease Activity Index (CDAI) scores. The CDAI is calculated at the specified time points using the formula: CDAI = SJC(28) + TJC(28) + PGA + EGA SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) Interpretation: A lower CDAI score from Baseline would mean improvement in disease activity and an increase in CDAI score from Baseline would mean an increase in disease activity or a worsening in disease activity. Scores: 0.0-2.8 = Range for Remission; 2.9-10.0 = Range for Low disease activity; 10.1-22.0 Range for Moderate disease activity; 22.1-76 Range for High disease activity.Total range is from 0-100, with the high scores representing high disease activity.
COMPLETED
PHASE4
20 participants
Baseline, Month 3 and Month 6
2019-01-18
Participant Flow
Participant milestones
| Measure |
Group 1
Ten (10) Patients were treated with 80 U of ACTH once weekly and MTX 12.5-25 mg/week for a period of 6 months. Eight (8) Patients completed the 6 month trial in this group
|
Group 2
Ten (10) patients were treated with 80 U of ACTH twice a week and MTX 12.5-25 mg/week for a 6 month period. Nine (9) patients completed the trial in this group over the 6 month period.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients
Baseline characteristics by cohort
| Measure |
Corticotrophin 80 Units
n=10 Participants
Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) weekly
corticotrophin 80 units: Comparison of different dosages of the drug. Ten patients will receive 80 units of corticotrophin weekly. Ten patients will receive 80 units bi-weekly of corticotrophin
|
Corticotrophin 80 Units Twice a Week
n=10 Participants
Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) twice a week
corticotrophin 80 units: Comparison of different dosages of the drug. Ten patients will receive 80 units of corticotrophin weekly. Ten patients will receive 80 units bi-weekly of corticotrophin
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
57 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3 and Month 6Population: Total number of Patients who complete 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2
To evaluate the effect of the use of 2 doses of corticotrophin (ACTH) as a treatment in patients with early onset rheumatoid arthritis as an alternative to conventional steroid therapy by evaluating the change from baseline in the clinical findings as measured by Clinical Disease Activity Index (CDAI) scores. The CDAI is calculated at the specified time points using the formula: CDAI = SJC(28) + TJC(28) + PGA + EGA SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) Interpretation: A lower CDAI score from Baseline would mean improvement in disease activity and an increase in CDAI score from Baseline would mean an increase in disease activity or a worsening in disease activity. Scores: 0.0-2.8 = Range for Remission; 2.9-10.0 = Range for Low disease activity; 10.1-22.0 Range for Moderate disease activity; 22.1-76 Range for High disease activity.Total range is from 0-100, with the high scores representing high disease activity.
Outcome measures
| Measure |
Group 1
n=9 Participants
Ten (10) Patients were treated with 80 U of ACTH once weekly and MTX 12.5-25 mg/week for a period of 6 months. Eight (8) Patients completed the 6 month trial in this group
|
Group 2
n=8 Participants
Ten (10) patients were treated with 80 U of ACTH twice a week and MTX 12.5-25 mg/week for a 6 month period. Nine (9) patients completed the trial in this group over the 6 month period.
|
|---|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Baseline · remission
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Baseline · low disease activity
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Baseline · moderate disease activity
|
0 Participants
|
0 Participants
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Baseline · high disease activity
|
9 Participants
|
8 Participants
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Month 3 · remission
|
3 Participants
|
1 Participants
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Month 3 · low disease activity
|
2 Participants
|
4 Participants
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Month 3 · moderate disease activity
|
4 Participants
|
2 Participants
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Month 3 · high disease activity
|
0 Participants
|
1 Participants
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Month 6 · remission
|
2 Participants
|
3 Participants
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Month 6 · low disease activity
|
4 Participants
|
3 Participants
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Month 6 · moderate disease activity
|
2 Participants
|
2 Participants
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Month 6 · high disease activity
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Total number of Patients who complete 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2
To compare the number of patients who have synovitis, oseitis and erosions at Baseline, Month 3 and Month 6. Normal range for synovitis, osteitis and erosions is zero (0)
Outcome measures
| Measure |
Group 1
n=9 Participants
Ten (10) Patients were treated with 80 U of ACTH once weekly and MTX 12.5-25 mg/week for a period of 6 months. Eight (8) Patients completed the 6 month trial in this group
|
Group 2
n=8 Participants
Ten (10) patients were treated with 80 U of ACTH twice a week and MTX 12.5-25 mg/week for a 6 month period. Nine (9) patients completed the trial in this group over the 6 month period.
|
|---|---|---|
|
Evaluation of MRI Structural Improvements
Baseline : synovitis
|
8 participants
|
7 participants
|
|
Evaluation of MRI Structural Improvements
Baseline : osteitis
|
8 participants
|
4 participants
|
|
Evaluation of MRI Structural Improvements
Baseline : erosions
|
9 participants
|
8 participants
|
|
Evaluation of MRI Structural Improvements
Month 3 : synovitis
|
6 participants
|
7 participants
|
|
Evaluation of MRI Structural Improvements
Month 3 : osteitis
|
6 participants
|
6 participants
|
|
Evaluation of MRI Structural Improvements
Month 3 : erosions
|
9 participants
|
8 participants
|
|
Evaluation of MRI Structural Improvements
Month 6 : synovitis
|
5 participants
|
7 participants
|
|
Evaluation of MRI Structural Improvements
Month 6 : osteitis
|
4 participants
|
4 participants
|
|
Evaluation of MRI Structural Improvements
Month 6 : erosions
|
7 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Population: Total number of Patients with erosions who completed 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2
Comparison of the change in the number of erosions seen in the joints of the hand and wrist as measured by Magnetic Resonance Imaging (MRI) findings. Regression indicates improvement in the number of erosions seen from Baseline and Progression indicates worsening in the number of erosions seen from Baseline. Normal range is zero (0).
Outcome measures
| Measure |
Group 1
n=9 Participants
Ten (10) Patients were treated with 80 U of ACTH once weekly and MTX 12.5-25 mg/week for a period of 6 months. Eight (8) Patients completed the 6 month trial in this group
|
Group 2
n=8 Participants
Ten (10) patients were treated with 80 U of ACTH twice a week and MTX 12.5-25 mg/week for a 6 month period. Nine (9) patients completed the trial in this group over the 6 month period.
|
|---|---|---|
|
Number of Participants With Increased or Decreased Erosions of the Hand and Wrist
Month 3 : Progressed erosions
|
1 participants
|
3 participants
|
|
Number of Participants With Increased or Decreased Erosions of the Hand and Wrist
Month 3 : Regressed erosions
|
0 participants
|
2 participants
|
|
Number of Participants With Increased or Decreased Erosions of the Hand and Wrist
Month 6 : Progressed erosions
|
2 participants
|
2 participants
|
|
Number of Participants With Increased or Decreased Erosions of the Hand and Wrist
Month 6 : Regressed erosions
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Month 6Population: Total number of Patients who complete 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2
Comparison of the clinical findings as measured by the Clinical Disease Activity Index (CDAI) versus the structural findings as measured by Magnetic Resonance Imaging (MRI). Improvement is measured as a reduction in CDAI score from Baseline to Month 6 and improvement in MRI is regression of erosions, oseitis and synovitis at month 6. Norman MRI score is zero (0). CDAI: 0.0-2.8 remission; 2.9-10.0 low disease activity; 10.1-22 moderate disease activity; 22.1-76 high disease activity. A decrease in CDAI score is improvement
Outcome measures
| Measure |
Group 1
n=9 Participants
Ten (10) Patients were treated with 80 U of ACTH once weekly and MTX 12.5-25 mg/week for a period of 6 months. Eight (8) Patients completed the 6 month trial in this group
|
Group 2
n=8 Participants
Ten (10) patients were treated with 80 U of ACTH twice a week and MTX 12.5-25 mg/week for a 6 month period. Nine (9) patients completed the trial in this group over the 6 month period.
|
|---|---|---|
|
Comparison of Clinical Disease Activity Index (CDAI) Scores to Positive Magnetic Resonance Imaging (MRI) Findings
# of patients whose CDAI score improved
|
8 participants
|
8 participants
|
|
Comparison of Clinical Disease Activity Index (CDAI) Scores to Positive Magnetic Resonance Imaging (MRI) Findings
# of patients whose overall MRI improved
|
6 participants
|
5 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Population: Total number of Patients who complete 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2
comparisons not statistical analysis will be made from Baseline and Month 6 of the C- reactive Protein (CRP) values and Erythrocyte Sedimentation Rate (ESR) to determine the number of patients whose test result improved or worsenedCRP value (normal range \<1.0 mg/dl). ESR (normal range 0-28 mm/hr) . If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved.
Outcome measures
| Measure |
Group 1
n=9 Participants
Ten (10) Patients were treated with 80 U of ACTH once weekly and MTX 12.5-25 mg/week for a period of 6 months. Eight (8) Patients completed the 6 month trial in this group
|
Group 2
n=8 Participants
Ten (10) patients were treated with 80 U of ACTH twice a week and MTX 12.5-25 mg/week for a 6 month period. Nine (9) patients completed the trial in this group over the 6 month period.
|
|---|---|---|
|
Participants With Increased and Decreased C-Reactive Protein (CRP) Values and Erythrocyte Sedimentation Rates (ESR)
CRP Values · # of patients with Increased values
|
1 Participants
|
1 Participants
|
|
Participants With Increased and Decreased C-Reactive Protein (CRP) Values and Erythrocyte Sedimentation Rates (ESR)
CRP Values · # of patient with Decreased values
|
8 Participants
|
7 Participants
|
|
Participants With Increased and Decreased C-Reactive Protein (CRP) Values and Erythrocyte Sedimentation Rates (ESR)
ESR Values · # of patient with Decreased values
|
9 Participants
|
8 Participants
|
|
Participants With Increased and Decreased C-Reactive Protein (CRP) Values and Erythrocyte Sedimentation Rates (ESR)
ESR Values · # of patients with Increased values
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1
Group 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joanne Sagliani
Arthritis & Rheumatic Disease Specialties
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place