N/A
N=808
An Observational Study to Describe in Routine Clinical Practice the Treatment Patterns of Usage of Biological DMARDs in RA Patients.
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02590562 ↗Enrolled (actual)
808
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy — 44; 9; 26; 5 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Routine clinical practice (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy |
44; 9; 26; 5; 718 | — |
| PRIMARY Number of Participants Receiving a Biological Agent Concomitant With Other Drugs |
238; 450; 137; 153 | — |
| PRIMARY Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents |
4; 8; 63; 9 | — |
| PRIMARY Average Weekly Dose of Treatment for Each Biological Agent |
20.1; 94.5; 38.2; 33.1 | — |
| PRIMARY Average Duration of Treatment for Each Biological Agent |
12.7; 4.7; 25.5; 34.5 | — |
| PRIMARY Number of Participants With Previous Use of the Same Biological Agent |
58 | — |
| PRIMARY Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past |
13; 10; 54; 10; 2; 7 | — |
| PRIMARY Average Weekly Dose of Each Concomitant Glucocorticoid |
57.8; 3.8; 638.8; 59.7 | — |
| PRIMARY Average Duration of Treatment With Each Concomitant External Medicine |
1.0; 24.0; 4.5; 1.0; 1.0; 5.5 | — |
| PRIMARY Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs |
354; 129; 7; 83; 9; 68 | — |
| PRIMARY Average Weekly Dose of Each Concomitant csDMARD |
46.9; 26.9; 75.0; 1.4; 15.4; 250.0 | — |
| PRIMARY Average Duration of Treatment With Each Concomitant csDMARD |
260.8; 251.1; 448.0; 443.7; 413.4; 95.2 | — |
| PRIMARY Average Daily Dose of Each Currently Concomitant NSAIDs |
200.0; 550.0; 157.1; 16.0; 143.9; 12.8 | — |
| PRIMARY Average Daily Dose of Each Previously Concomitant NSAIDs |
525.0; 150.0; 135.0; 13.1; 200.0; 266.7 | — |
| SECONDARY Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage |
275; 2; 8; 279 | — |
| SECONDARY Weight |
58.9 | — |
| SECONDARY Height |
161.6 | — |
| SECONDARY Number of RA Related Operations |
0.1 | — |
| SECONDARY RA Duration Since Diagnosis |
3.2 | — |
| SECONDARY Number of Participants With RA Duration |
176; 80; 59; 42 | — |
| SECONDARY Number of Participants With Concurrent RA Extra-articular Symptoms |
18; 0; 22; 0; 2 | — |
| SECONDARY Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate |
5 | — |
| SECONDARY C-Reactive Protein (CRP) Values |
27.7 | — |
| SECONDARY Number of Participants With Abnormal CRP Values |
209 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) Values |
42.4 | — |
| SECONDARY Number of Participants With Abnormal ESR Values |
276 | — |
| SECONDARY Hemoglobin Values |
117.1 | — |
| SECONDARY Number of Participants With Anemia |
147 | — |
| SECONDARY Number of Participants With Positive Anti-cyclic Citrullinated Peptide (ACCP) Antibody |
144 | — |
| SECONDARY Number of Participants With Positive Rheumatoid Factor (RF) |
184 | — |
| SECONDARY Triglyceride Values |
1.3 | — |
| SECONDARY Number of Participants With Abnormal Triglyceride Values |
47 | — |
| SECONDARY Total Cholesterol Values |
4.3 | — |
| SECONDARY Number of Participants With Abnormal Total Cholesterol Values |
35 | — |
| SECONDARY Swollen Joint Count (SJC) |
4.8 | — |
| SECONDARY Tender Joint Count (TJC) |
6.7 | — |
| SECONDARY Disease Activity Score Based on 28-Joint Count (DAS28) |
4.4 | — |
| SECONDARY Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28 |
135; 174; 51; 52 | — |
| SECONDARY Clinical Disease Activity Index (CDAI) Scores |
20.2 | — |
| SECONDARY Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI |
278; 273; 207; 43 | — |
| SECONDARY Simplified Disease Activity Index (SDAI) |
27.2 | — |
| SECONDARY Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI |
158; 117; 56; 12 | — |
| SECONDARY Number of Participants With Duration of Treatment of Biological Agent |
503; 86; 96; 117 | — |
| SECONDARY DAS28 by Duration of Treatment of Biological Agent |
4.6; 3.5; 3.9; 3.2 | <0.0001 sig |
| SECONDARY DAS28 by Biological Agent as Monotherapy or Combination With csDMARDs |
4.8; 4.3 | 0.0108 sig |
| SECONDARY Physician's Global Assessment (PGA) of Disease Activity |
4.2 | — |
| SECONDARY Patient's Global Assessment (PtGA) of Disease Activity |
4.4 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |
11.9 | — |
| SECONDARY Participant's Fatigue Assessment |
3.7 | — |
| SECONDARY Participant's Pain Assessment |
4.2 | — |
Summary
This observational study will describe the treatment patterns of usage of biological DMARDs in routine clinical practice and the demographics and RA disease characteristics in patients suffering from rheumatoid arthritis. Patients will be recruited and examined the same day when recruited. There will be no follow up visit or treatment period only one visit in this study.
Eligibility Criteria
Inclusion Criteria
- Patients at least 18 years of age.
- Patients with a diagnosis of RA according to the revised ACR criteria.
- Patients receiving treatment of launched biological DMARDs.
Exclusion Criteria
- Patients who received biological DMARDs due to clinical trials or biologics not launched.
- Patients who are considered not appropriate for study due to other reasons at physicians' discretion.
Data sourced from ClinicalTrials.gov (NCT02590562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.