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Could a rheumatoid arthritis drug help heart transplant patients?

NCT ID NCT03644667

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding tocilizumab (Actemra) to standard anti-rejection medicines helps heart transplant recipients do better one year after surgery. 385 participants received either tocilizumab or a placebo alongside their usual drugs. The goal was to see if the drug reduces rejection, harmful antibodies, and heart damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tocilizumab (Actemra)
What this could lead to
If it works, this could mean fewer rejection episodes and better heart function for transplant recipients, potentially improving long-term survival.
What could go wrong
This is a phase 2 trial, so results are still preliminary. Tocilizumab may not reduce rejection or could increase infection risk. Lifelong anti-rejection drugs are still needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

385 people

The number who actually took part.

Started

Dec 2018

Finished

Mar 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion Criteria- Study Entry 1. Subject must be able to understand and provide informed consent; 2. Is a candidate for a primary heart transplant (listed as a heart transplant only); 3. No desensitization therapy prior to transplant; 4. Agreement to use contraception: according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. * Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from the above referenced list to be used for the duration of the study * Those who choose oral contraception must agree to use a second form of contraception after administration of study drug for a period of 1 year after the last dose of study drug. 5. Mechanical support or investigational drug trials where the intervention ends at the time of transplantation are permitted; 6. In the absence of contraindication, vaccinations should be up to date for hepatitis B, influenza, pneumococcal, zoster, and Measles, Mumps, \& Rubella (MMR); and 7. Subjects from areas of endemic coccidioidomycosis are eligible for inclusion but must be treated prophylactically with fluconazole or itraconazole. Inclusion Criteria - Randomization 1. Recipient of a primary heart transplant; 2. Negative virtual crossmatch (according to local center criteria); 3. No desensitization therapy prior to transplant; 4. Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) prior to randomization; and 5. Agreement to use contraception: according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. * Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from the above referenced list to be used for the duration of the study * Those who choose oral contraception must agree to use a second form of contraception after administration of study drug for a period of 1 year after the last dose of study drug. 6. Negative SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) test result performed within 48 hours of transplant (SARS-CoV-2 is the virus that causes COVID-19) Exclusion Criteria: Exclusion Criteria Study Entry 1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol; 2. Candidate for a multiple solid organ or tissue transplants; 3. Prior history of organ or cellular transplantation requiring ongoing systemic immunosuppression; 4. Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period; 5. History of severe allergic and/or anaphylactic reactions to humanized or murine monoclonal antibodies; 6. Known hypersensitivity to tocilizumab (Actemra®); 7. Previous treatment with tocilizumab (Actemra®); 8. Human Immunodeficiency Virus (HIV) positive; 9. Hepatitis B surface antigen positive; 10. Hepatitis B core antibody positive; 11. Hepatitis C virus antibody positive (anti-HCV Ab+) who are either untreated or, have failed to demonstrate sustained viral remission for more than 12 months (after anti-viral treatment); 12. Recipient of a Hepatitis C virus nucleic acid test (NAT) positive donor organ; 13. Subjects must be tested for latent TB infection (LTBI) within a year prior to transplant: --Subjects with a positive test for LTBI must complete appropriate therapy for LTBI. ---A Subject is considered eligible only if they have a negative test for LTBI within one year prior to transplant OR \---- if they have completed appropriate LTBI therapy within one year prior to transplant. 14. Subjects with a previous history of active Tuberculosis (TB); 15. Subjects with a history of splenectomy; 16. Known active current viral, fungal, mycobacterial or other infections not including (left ventricular assist device \[LVAD\]) driveline infections; 17. History of malignancy less than 5 years in remission. --Any history of adequately treated in-situ cervical carcinoma, low grade prostate carcinoma, or adequately treated basal or squamous cell carcinoma of the skin will be permitted. 18. History of hemolytic-uremic syndrome/ thrombotic thrombocytopenia purpura; 19. History of demyelinating disorders such as: * multiple sclerosis, * chronic inflammation, * demyelinating polyneuropathy. 20. History of gastrointestinal perforations, active inflammatory bowel disease or diverticulitis; 21. Any previous treatment with alkylating agents such as chlorambucil or, total lymphoid irradiation; 22. Radiation therapy within 3 weeks before enrollment. --Enrollment of subjects who require concurrent radiotherapy should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy. 23. Subjects with a hemoglobin \<7.0gm/dL (last measurement within 7 days prior to transplant); 24. Subjects with a platelet count of less than 100,000/mm\^3 (last measurement within 7 days prior to transplant); 25. Subjects with an absolute neutrophil count (ANC) of less than 2,000/mm\^3 (last measurement within 7 days prior to transplant); 26. Subjects with Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels \>3 x Upper Limit of Normal (ULN); 27. Subjects who are administered or intended to be administered cytolytic or anti-cluster of differentiation 25 (CD25) monoclonal antibody agents as induction therapy in the immediate post-transplant period; 28. Intent to give the recipient a live vaccine within 30 days prior to randomization; 29. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may: * pose additional risks from participation in the study, * may interfere with the participant's ability to comply with study requirements, or * that may impact the quality or interpretation of the data obtained from the study. Exclusion Criteria - Randomization 1. Recipient of multiple solid organ or tissue transplants; 2. Recipient of ex vivo preserved hearts and hearts donated after cardiac death (DCD); 3. Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period; 4. History of severe allergic anaphylactic reactions to humanized or murine monoclonal antibodies; 5. Known hypersensitivity to tocilizumab (Actemra®); 6. Previous treatment with tocilizumab (Actemra®); 7. HIV positive; 8. Hepatitis B surface antigen positive; 9. Hepatitis B core antibody positive; 10. Hepatitis B negative transplant recipient that received a transplant from a hepatitis B core antibody positive donor; 11. HCV+ subject(s) who are either untreated or have failed to demonstrate sustained viral remission for more than 12 months after anti-viral treatment; 12. Recipient of a hepatitis C virus nucleic acid test (NAT) positive donor organ; 13. Subject's organ donor tests positive for SARS-CoV-2 by real-time reverse transcription polymerase chain reaction (SARS-CoV-2 is the virus that causes COVID-19). 14. Subjects with a previous history of active (TB); 15. Subjects must be tested for latent TB infection (LTBI) within a year prior to transplant: --Subjects with a positive test for LTBI must complete appropriate therapy for LTBI. ---A Subject is considered eligible only if they have a negative test for LTBI within one year prior to transplant OR \---- if they have completed appropriate LTBI therapy within one year prior to transplant. 16. Subjects with a history of splenectomy; 17. Known active current viral, fungal, mycobacterial or other infections, not including (left ventricular assist device \[LVAD\]) driveline infections; 18. History of malignancy less than 5 years in remission. --Any history of adequately treated in-situ cervical carcinoma, low grade prostate carcinoma, or adequately treated basal or squamous cell carcinoma of the skin will be permitted. 19. History of hemolytic-uremic syndrome/ thrombotic thrombocytopenia purpura; 20. History of demyelinating disorders; 21. History of gastrointestinal perforations, active inflammatory bowel disease or diverticulitis; 22. Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation; 23. Radiation therapy within 3 weeks before randomization. --Enrollment of subjects who require concurrent radiotherapy should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy. 24. Subjects with a hemoglobin \<7.0gm/dL within 7 days prior to randomization; 25. Subjects with a platelet count of less than 100,000/mm\^3 within 7 days prior to randomization; 26. Subjects with an absolute neutrophil count (ANC) of less than 2,000/mm\^3 within 7 days prior to randomization; 27. Subjects with AST or ALT levels \>3 x ULN; 28. Subjects who are administered or intended to be administered cytolytic or anti- CD25 monoclonal antibody agents as induction therapy in the immediate post- transplant period; 29. Receipt of a live vaccine within 30 days prior to randomization; 30. Use of investigational drugs after transplantation; 31. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, * may pose additional risks from participation in the study, * may interfere with the participant's ability to comply with study requirements, or * that may impact the quality or interpretation of the data obtained from the study. 32. Subjects with known donor-specific antibody at the time of evaluation of antibodies for heart transplant surgery (within 6 months).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Allegheny General Hospital (PAAG)

    Pittsburgh, Pennsylvania, 15212, United States

  • Baylor University Medical Center (TXTX)

    Dallas, Texas, 75246, United States

  • Cedars Sinai Medical Center (CACS)

    Beverly Hills, California, 90211, United States

  • Cleveland Clinic Foundation (OHCC)

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center (NYCP)

    New York, New York, 10032, United States

  • Duke University Medical Center (NCDU)

    Durham, North Carolina, 27710, United States

  • Hospital of the University of Pennsylvania (PAUP)

    Philadelphia, Pennsylvania, 19104, United States

  • Massachusetts General Hospital (MAMG)

    Boston, Massachusetts, 02114, United States

  • Montefiore Medical Center (NYMA)

    The Bronx, New York, 10467, United States

  • Mount Sinai Medical Center (NYMS)

    New York, New York, 10029, United States

  • Northwestern Memorial Hospital (INLM)

    Chicago, Illinois, 60611, United States

  • Penn State Health: Milton S. Hershey Medical Center (PAHE)

    Hershey, Pennsylvania, 17033, United States

  • St. Luke's Hospital of Kansas City (MOLH)

    Kansas City, Missouri, 64111, United States

  • Stanford Health Care (CASU)

    Stanford, California, 94305, United States

  • Tampa General Hospital (FLTG)

    Tampa, Florida, 33606, United States

  • Tufts Medical Center (MANM)

    Boston, Massachusetts, 02111, United States

  • University of California, San Diego: Sulpizio Cardiovascular Center (CASD)

    La Jolla, California, 92037, United States

  • University of Nebraska Medical Center (NEUN)

    Omaha, Nebraska, 68198, United States

  • University of Utah (UTMC)

    Salt Lake City, Utah, 84132, United States

  • Vanderbilt University Medical Center (TNVU)

    Nashville, Tennessee, 37232, United States

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