Change From Baseline in Clinical Disease Activity Index (CDAI) Score
| Group | Value (Participants) |
|---|---|
| Group 1 | 0 |
| Group 2 | 0 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients
NCT01948388Sept 2013 to Sept 2016
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of the study is to evaluate the effect of the utilization of two 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 well as the structural findings on Magnetic Resonance Imaging (MRI). Corticotrophin (ACTH) may prevent the well documented structural progression damage in RA patients using disease-modifying antirheumatic drug (DMARD) therapy alone.
Active comparator
corticotrophin 80 units
Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) weekly
Active comparator
corticotrophin 80 units twice a week
Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) twice a week
Outcomes the sponsor listed as primary.
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Time frame · Baseline, Month 3 and Month 6
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.
Evaluation of MRI Structural Improvements
Time frame · Baseline, 3 months, 6 months
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)
Number of Participants With Increased or Decreased Erosions of the Hand and Wrist
Time frame · Month 3 and Month 6
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).
Comparison of Clinical Disease Activity Index (CDAI) Scores to Positive Magnetic Resonance Imaging (MRI) Findings
Time frame · Month 6
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
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Group 1 | 0 |
| Group 2 | 0 |
| Group | Value (participants) |
|---|---|
| Group 1 | 8 |
| Group 2 | 7 |
| Group | Value (participants) |
|---|---|
| Group 1 | 1 |
| Group 2 | 3 |
| Group | Value (participants) |
|---|---|
| Group 1 | 8 |
| Group 2 | 8 |
| Group | Value (Participants) |
|---|---|
| Group 1 | 8 |
| Group 2 | 7 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Group 1Ten (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 | – | 0 / 10 | 0 / 10 |
| Group 2Ten (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. | – | 0 / 10 | 0 / 10 |
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