Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to find patterns in the use of non-biological DMARDs as the initial treatment of RA and how adverse events (AEs), intolerance or lack of efficacy may impact therapeutic decisions in real life in the Spanish Andalusian region.
Interventions
None listed
Sponsors
Fundación Andaluza de Reumatología
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of both sexes ≥ 18 years. * Patients diagnosed with RA (according to the American College of Rheumatology (ACR) 2010 criteria) between January 2008 and December 2012 and who have initiated treatment with at least one synthetic DMARD during that period. * Patients who have given written informed consent for their data to be collected and reviewed.
Exclusion criteria
* Patients who are already participating in a clinical trial/s at the moment of participation in this study. * Patients with whom it is suspected there will be insufficient information to complete the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice | 6 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Present Adverse Events While on Treatment With Synthetic Disease-modifying Antirheumatic Drug (DMARDs) and Require a Dose Reduction of the Synthetic DMARD in Question | 6 years | — |
| Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal | 6 years | — |
| Percentage of Patients Who Require an Alternative DMARD Due to Lack of Efficacy, Defined as Primary or Secondary Failure According to the Rheumatologist In-charge of Treatment | 6 years | — |
| Percentage of Patients Who Receive Subcutaneous Methotrexate | 6 years | — |
| Exposure Time of Methotrexate | 6 years | methotrexate |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Whom Fulfilled the ACR Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period. | 301 |
| Total | 301 |
Baseline characteristics
| Characteristic | Patients Whom Fulfilled the ACR |
|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 14 |
| Sex: Female, Male Female | 214 Participants |
| Sex: Female, Male Male | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 301 |
| serious Total, serious adverse events | 0 / 301 |
Outcome results
Primary
Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice
Time frame: 6 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Whom Fulfilled the ACR | Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice | 65.1 percentage of participants |
Secondary
Exposure Time of Methotrexate
methotrexate
Time frame: 6 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Whom Fulfilled the ACR | Exposure Time of Methotrexate | 19.2 months | Standard Deviation 16.5 |
Secondary
Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal
Time frame: 6 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Whom Fulfilled the ACR | Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal | 16.1 percentage of participants |
Secondary
Percentage of Patients Who Present Adverse Events While on Treatment With Synthetic Disease-modifying Antirheumatic Drug (DMARDs) and Require a Dose Reduction of the Synthetic DMARD in Question
Time frame: 6 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Whom Fulfilled the ACR | Percentage of Patients Who Present Adverse Events While on Treatment With Synthetic Disease-modifying Antirheumatic Drug (DMARDs) and Require a Dose Reduction of the Synthetic DMARD in Question | 10.5 percentage of participants |
Secondary
Percentage of Patients Who Receive Subcutaneous Methotrexate
Time frame: 6 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Whom Fulfilled the ACR | Percentage of Patients Who Receive Subcutaneous Methotrexate | 21.2 percentage of participants |
Secondary
Percentage of Patients Who Require an Alternative DMARD Due to Lack of Efficacy, Defined as Primary or Secondary Failure According to the Rheumatologist In-charge of Treatment
Time frame: 6 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Whom Fulfilled the ACR | Percentage of Patients Who Require an Alternative DMARD Due to Lack of Efficacy, Defined as Primary or Secondary Failure According to the Rheumatologist In-charge of Treatment | 6.9 percentage of participants |