[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site

Condition

Rheumatoid Arthritis

Treatment type

Interventional

Investigational product

Methotrexate

Phase

Phase 3

Sponsor

R-Pharm

ClinicalTrials.gov identifier

NCT03120949

Study number

CL04041024

Understanding clinical trials

Get answers to your questions about clinical trials.

About the study

The purpose of the study is to evaluate how safe, how effective and how well tolerated, the study drug Olokizumab is, in the long-term, in patients with Rheumatoid Arthritis (RA) who have previously taken part in and completed 24 weeks of blinded treatment in one of the core studies - CREDO 1, 2 or 3.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. route) of MTX 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher
  2. doses) during the core study and plan to maintain the same dose and route of administration for additional 12 weeks 4. Subjects must be willing to take folic acid or equivalent throughout the study.
Exclusion criteria
  1. condition) which would make this subject unsuitable for inclusion in the open-label extension (
  2. OLE) study in the Investigator's judgement. 2. Subject has evidence of active tuberculosis (
  3. TB) 3. Subject has planned surgery during the first 12 weeks of the OLE 4. Female subjects who are pregnant or who are planning to become pregnant during the study or within 6 months of the last dose of study drug 5. Female subjects of childbearing who are not willing to use a highly effective method of contraception during the study OR Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study. 6. Subject is unwilling or unable to follow the procedures outlined in the protocol 7. Other medical or psychiatric conditions, or lab abnormalities that may increase the potential risk associated with study participation and administration of investigational medicinal products (IMPs), or that may affect study results interpretation and, as per Investigator's judgement, make the subject ineligible The following restrictions may affect a subject's ability to participate in this study: - Availability to attend visits according to the protocol within the allowed window period - Ability to perform self-administration of study drug and availability of caregiver to administer study drug - Concomitant medication restrictions as described in the Informed Consent Form and protocol (water and concomitant medications are
  4. permitted) for at least 9 hours prior to all study visits 8. Subject with a positive or repeated indeterminate interferon-gamma release assay (
  5. IGRA) result at Week 22 of the core study - Subjects may be enrolled in the OLE study if they fulfill all 3 of the following criteria prior to the first dose of study treatment: 1. Active TB is ruled out by a certified TB specialist or pulmonologist who is familiar with diagnosing and treating TB (as acceptable per local practice); 2. The subject starts prophylaxis for LTBI according to country-specific/Centers for Disease Control and Prevention (
  6. CDC) guidelines (see Appendix 4 [Section 13.4]) (treatment with isoniazid for 6 months is not an appropriate The Investigator (or
  7. designee) should review these restrictions with the subject during the Screening Period to determine any potential challenges in the subject's ability to comply with the protocol. Subjects not able to comply with the above mentioned restrictions should not be enrolled into the study.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site