N/A
N=209
An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01664117 ↗Enrolled (actual)
209
Serious AEs
3.4%
Results posted
Apr 2016
Primary outcome: Primary: Number of Participants With Level of Education Completed — 01; 15; 86; 59 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Level of Education Completed |
01; 15; 86; 59; 17; 28 | — |
| PRIMARY Number of Participants With Smoking Habits |
170; 15; 23; 01 | — |
| PRIMARY Smoking-habit for Smokers or Ex-smokers (Packs in Years) |
120.20; 122.26 | — |
| PRIMARY Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking ) |
18.73; 9.35 | — |
| PRIMARY Mean Time of Onset of Rheumatoid Arthritis |
13.45 | — |
| PRIMARY Number of Participants With Family History of Rheumatoid Arthritis |
15; 160; 34 | — |
| PRIMARY Number of Participants With Co-morbidities |
109; 100 | — |
| PRIMARY Number of Participants With Extra-articular Manifestations at Visit 1 |
59; 148; 02 | — |
| PRIMARY Mean Number of Painful and Swollen Joints at Visit 1 |
1.92; 0.84 | — |
| PRIMARY Physician's Global Assessment of Disease Activity at Visit 1 |
2.49 | — |
| PRIMARY Patient's Global Assessment of Disease Activity at Visit 1 |
3.11 | — |
| PRIMARY Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1 |
159; 165; 145; 173; 157; 140 | — |
| PRIMARY Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1 |
172; 162; 130; 104; 82; 76 | — |
| PRIMARY Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies |
125; 42; 42; 80; 35; 94 | — |
| PRIMARY Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1 |
180; 162 | — |
| PRIMARY Patient Pain Visual Analog Scale Score at Visit 1 |
3.09 | — |
| PRIMARY Number of Participants With Joint Damage at Visit 1 |
154; 55 | — |
| PRIMARY Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1 |
2.70 | — |
| PRIMARY Number of Participants With Disease Activity Score by Categorization at Visit 1 |
104; 43; 59; 03 | — |
| PRIMARY Mean Score on Clinical Disease Activity Index at Visit 1 |
8.36 | — |
| PRIMARY Number of Participants With Clinical Disease Activity by Categorization at Visit 1 |
33; 118; 52; 06 | — |
| PRIMARY Mean Score on Simple Disease Activity Index at Visit 1 |
8.76 | — |
| PRIMARY Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1 |
42; 110; 53; 04 | — |
| SECONDARY Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study |
209; 27 | — |
| SECONDARY Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug |
19.53; 89.81 | — |
| SECONDARY Number of Participants Who Received Each sDMARD Before The Study |
10; 5; 47; 48; 48; 27 | — |
| SECONDARY Number of Participants Who Received Last sDMARD Prescribed Before the Study |
1; 1; 13; 10; 1; 62 | — |
| SECONDARY Number of Participants Prescribed First bDMARD Before the Study |
126 | — |
| SECONDARY Number of Participants Who Received Each bDMARD Before the Study |
58; 48; 2; 61; 10; 4 | — |
| SECONDARY Mean Time Between the Last sDMARD and bDMARD Received at Visit 1 |
9.39; 1.78; 36.69 | — |
| SECONDARY Number of Participants With Changing the Previous sDMARD/ bDMARD |
343; 135; 25; 7; 40; 155 | — |
| SECONDARY Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy) |
2.63; 1.67 | — |
| SECONDARY Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment |
64; 95; 50 | — |
| SECONDARY Number of Participants Discontinued the Previous Treatment and Started the Study Treatment |
128; 21; 16; 22; 22 | — |
| SECONDARY Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment |
29.4; 31.9; 59.5; 16; 18.6; 10.1 | — |
| SECONDARY Number of Participants Treated With Concomitant Medications Before the Study |
140; 128; 19 | — |
| SECONDARY Number of Participants Received Current bDMARD Treatment at the Time of the Study |
39; 3; 26; 8; 122; 8 | — |
| SECONDARY Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy |
39; 48; 42 | — |
| SECONDARY Number of Participants With Reasons for Starting Current Biologic Monotherapy |
128; 21; 22; 22; 16 | — |
| SECONDARY Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study |
122; 71; 16 | — |
| SECONDARY Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA |
11.34; 10.23 | — |
| SECONDARY Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent) |
2.59; 2.69; 1.34; 0.53 | — |
| SECONDARY Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study |
2.52; 2.97; 8.66; 7.94; 8.94; 8.52 | — |
| SECONDARY Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score |
90; 57; 32; 30; 84; 67 | — |
| SECONDARY Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study |
2.16; 1.57; 0.96; 0.68 | — |
| SECONDARY Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study |
110; 70; 108; 54 | — |
| SECONDARY Number of Participants With Adverse Events Leading to a Change of Treatment |
96 | — |
| SECONDARY Number of Participants With Any Adverse Events and Any Serious Adverse Events |
27; 07 | — |
Summary
This observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arthritis receiving any biological therapies in monotherapy.
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/=18 years of age
- Patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs) or other biological drugs
- Patients treated with biologic DMARDs alone for at least 6 months
Exclusion Criteria
- Patients not willing or unable to give written informed consent for participation in this study
- Patients who are participating in any clinical trial at the time of this study
Data sourced from ClinicalTrials.gov (NCT01664117). 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.