Skip to main content

Table 1 Selection criteria

From: Novel optical spectral transmission (OST)-guided versus conventionally disease activity-guided treatment: study protocol of a randomized clinical trial on guidance of a treat-to-target strategy for early rheumatoid arthritis

Inclusion criteria

• Early (< 1 year) RA, fulfilling 2010 ACR/EULAR criteria

• Age ≥ 18 years

• Ability and willingness to give written informed consent

• Ability to comply with the study protocol

Exclusion criteria

• Significant visual deformations of hands or fingers (impeding HandScan analysis)

Other (joint) disease

• Concomitant or current inflammatory joint disease other than RA

• Porphyria (HandScan risk analysis).

Drug-specific

• Contraindication for methotrexate or prednisolone

• Glucocorticoids used for RA < 6 weeks prior to baseline (NB, inhaled glucocorticoids are allowed)

• Previous treatment with any (biological) DMARD that is used in the treatment of RA

• Treatment with any investigational agent within 4 weeks or period of five half-lives, whichever is longer, before screening

• Patients using photodynamic therapy medication (HandScan risk analysis)

General medical

• Pregnancy or breast-feeding

• History of alcohol or substance abuse within the 6 months prior to screening. Alcohol abuse is defined as more than 3 units per day

• Neuropathies or other painful conditions that might interfere with pain evaluation