Health Condition 1: M248- Other specific joint derangements,not elsewhere classified
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Ajanta Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 and 75 years (both inclusive). 2. Patients who are on stable maximum tolerable dose of MTX and /OR other conventional DMARD’s since last 4 weeks. 3. Patients having a DAS28 score = 3.2 at baseline. 4. Patients with ability to understand and provide written informed consent, which must have been obtained prior to screening. 5. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who are hypersensitive to Iguratimod or any of its components. 2. Female patients who are pregnant or lactating or planning to become pregnant during the study period. 3. Females who are not ready to use acceptable contraceptive methods during the course of the study. 4. Patients who are on Biologicals for the treatment of RA. 5. Patients with elevated liver enzymes (SGPT, SGOT) and clinically significant impaired hepatic function. 6. Patients with bone marrow hypoplasia. (WBC 7. Patients with estimated glomerular filtration rate (eGFR) 8. Patients with known case of clinically significant psychiatric disease, cerebrovascular disease, cardiovascular disease, gastrointestinal disease, infective or any acute or chronic uncontrolled systemic diseases that may affect patient safety. 9. Patients with history of drug or substance (alcohol/drug) abuse within previous 1 year. 10. Patients with medical history of oncological conditions since last 5 years. 11. Patients with concurrent participation in another clinical trial within 90 days prior to signing informed consent form. 12. Patients with suspected inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients reporting incidences of AE during the study and their assessment with respect to intensity, duration, pattern and causal relationship to the study medication. •Proportion of patients reporting incidences of SAE during the study and their assessment with respect to intensity, duration, pattern and causal relationship to the study medication. •Changes in laboratory safety parameters from baseline to end of the study. Timepoint: Adverse events, SAE or abnormal lab values | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients meeting the American College of Rheumatology 20% and 50% (ACR20 and ACR50) response criteria at the end of the study. • Mean reduction in DAS 28 at the end of the study. Change in mean VAS score for pain assessment from baseline to end of the study visit.Timepoint: Week 24 | — |
Countries
India
Contacts
Public ContactDr Ravindra Mote
Mediclin Clinical Research
Outcome results
None listed