Arthritis Clinical Trials

This Postmarketing observational study (PMOS) will be conducted in a prospective, single-arm, multicenter, multi-country format.

According to the requirements for non-interventional or observational trials, no additional diagnostic or monitoring procedures will be applied to the patients included in the trial other than those which would ordinarily be applied in the course of the particular therapeutic strategy. Only data which are part of routine will be collected.

As this study is observational in nature, the follow-up visits are not interventional and strictly scheduled, but rather left to the judgment of each investigator within the 12-month study period for each patient.

Failure to observe these usual practice intervals of patient visits will not constitute a breach or violation of the protocol.

To optimize data collection, five (5) patient visits are indicated within the 12-month observational period:

• Visit 0 (V0): Baseline
• Visit 1 (V1): Follow-up at 3 months
• Visit 2 (V2): Follow-up at 6 months
• Visit 3 (V3): Follow-up at 9 months
• Visit 4 (V4): Follow-up at 12 months (Study End). A patient may withdraw from this Postmarketing observational study ( PMOS) at any time without prejudice. If the physician, for any reason, decides it is in the best interest of the patient to permanently discontinue adalimumab, treatment should be stopped. The reason should be documented in the Case report form (CRF). The next routine follow-up visit will be the termination visit for the patient.