Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)

Browse trials for

• Arthritis 3,554
• Arthritis, Rheumatoid 2,888

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 617 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Lead sponsor

Celltrion is the lead sponsor of 76 studies on the registry; 3 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 13 (72%) have results posted.

Study arms

• Active comparator
  CT-P13

  Drug: Infliximab

• Active comparator
  Remicade

  Drug: Infliximab

Interventions

• DrugInfliximab

  Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.

  Also known as: remicade

Primary outcomes

1. PK equivalence to remicade

   Time frame: PK sampling at week 30

Secondary outcomes

1. efficacy endpoint

   -ACR criteria comparison with Baseline at Weeks 14,30,54

   Time frame: up to week 54.

2. efficacy endpoint

   - Time to onset of ACR20 response

   Time frame: Up to week 54.

3. efficacy endpoint

   - Mean decrease in disease activity measured by DAS28 comparison with Baseline at week 30

   Time frame: Up to week 54.

4. efficacy endpoint

   - Proportion of patients with a good response, defined according to the EULAR response criteria

   Time frame: Up to week 54.

5. efficacy endpoint

   - ACR20 at weeks 14 and 54

   Time frame: Up to week 54.

6. efficacy endpoint

   - ACR50 and ACR70 at weeks 14, 30, and 54

   Time frame: Up to week 54.

7. efficacy endpoint

   - Hybrid ACR response at weeks 14, 30, and 54

   Time frame: Up to week 54.

8. efficacy endpoint

   - SDAI and CDAI at weeks 14, 30, and 54

   Time frame: Up to week 54.

9. efficacy endpoint

   - Joint damage progression at week 54

   Time frame: Up to week 54.

10. efficacy endpoint

    - SF-36 at weeks 14, 30, and 54

    Time frame: Up to week 54.

11. efficacy endpoint

    - Fatigue

    Time frame: Up to week 54.

12. efficacy endpoint

    - Number of patients requiring salvage retreatment at weeks 30 and 54

    Time frame: Up to week 54.

Publications

• Eser A, Reinisch W, Schreiber S, Ahmad T, Boulos S, Mould DR. Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody Detection. J Clin Pharmacol. 2021 Feb;61(2):224-233. doi: 10.1002/jcph.1732. Epub 2020 Sep 9. PubMed 32905628 ↗
• Yoo DH, Racewicz A, Brzezicki J, Yatsyshyn R, Arteaga ET, Baranauskaite A, Abud-Mendoza C, Navarra S, Kadinov V, Sariego IG, Hong SS, Lee SY, Park W. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016 Apr 2;18:82. doi: 10.1186/s13075-016-0981-6. PubMed 27038608 ↗
• Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, Kovalenko V, Prodanovic N, Abello-Banfi M, Gutierrez-Urena S, Morales-Olazabal L, Tee M, Jimenez R, Zamani O, Lee SJ, Kim H, Park W, Muller-Ladner U. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013 Oct;72(10):1613-20. doi: 10.1136/annrheumdis-2012-203090. Epub 2013 May 16. PubMed 23687260 ↗