Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Clinical response type ACR20 (Decrease of at least 20% in the number of painful joints and in the number of swollen joints. Also, at least a 20% improvement in three of the five following parameters: 1) Patient's pain assessment. Evaluated on Visual Analogue Scale from 0 to 10, where 0=no pain and 10=maximum pain); 2) Patient's global assessment of disease activity (PGA). Evaluated on a scale from 0 to 10, where 0=no activity and 10=maximum activity; 3) Physician's global assessment of disease activity (Medical doctor(MD) global). Evaluated on a scale from 0 to 10, where 0=no activity and 10=maximum activity; 4) Patient self-assessed disability. Evaluated using the Health Assessment Questionnaire Disability Index (HAQ-DI) questionnaire on a scale of 0 to > 2, where 0= no disability and > 2= severe disability.; 5) Acute phase reactant: CRP or ESR). Measurement time: Weeks 4, 8, 12, 16, 20, 24, 28 and 36
Key secondary outcomes:
1. DAS28 scale (To calculate the DAS28, the following formula must be used: DAS28 = 0.56 (square root of the number of painful joints) + 0.28 (square root of the number of swollen joints) + 0.70 (acute phase reactant) + 0.014 (EGP)). Measurement time: Weeks 0, 4, 8, 12, 16, 20, 24, 28 and 36.
2. Clinical activity of the disease by DAS28 scale (It is classified using the value of the DAS28 scale: Remission [< 2.60]; Lower [2.60 to 3.20]; Moderate [3.30 to 5.10]; High [≥ 5.20]). Measurement time: Week 0, 4, 8, 12, 16, 20, 24, 28 and 36.
3. Clinical response according to EULAR criteria (It is classified based on the reduction in the baseline value of the DAS28 index and the level of disease activity: Good [Reduction ≥1.20 and low activity]; Moderate [Reduction >0.60 and <1.20 and low or moderate activity, or Reduction [≥1.20 and high or moderate activity]; No response [Reduction <0.60, or Reduction <1.20 and high activity]). Measurement time: Weeks 4, 8, 12, 16, 20, 24, 28 and 36.
4. Clinical activity of the disease by CDAI scale (The following formula is used CDAI = Painful joints (0-28) + Swollen joints (0-28) + EGP + EGM. It is classified in: Remission [≤ 2.80]; Low [> 2.80 – 10.00]; Moderate [> 10.00 – 22.00]; High [> 22.00]). Measurement time: Weeks 1, 2 and 3
5. Functional capacity (HAQ-DI questionnaire. Classification of disability in the patient HAQ-DI score in: No disability [0.000]; Mild to moderate [0.000 to 1,000]; Moderate to severe [1,001 to 2,000]; Severe to very severe [> 2,000]). Measurement time: Week 0, 1. 2, 3, 4, 8, 12, 16, 20, 24, 28 and 36.